Methods and systems for preventing bleeding from the left atrial appendage

ABSTRACT

The disclosure presents methods and systems for applying a suction force to a surface of a left atrial appendage (LAA) with a plurality of tubes. A method may include puncturing the surface of the LAA using a tissue-penetrating tip while the suction force is applied to the surface. The disclosure also presents methods and systems for inflating a first inflatable balloon within a cavity of a left atrial appendage (LAA). A method may include applying a suction force with at least one tube coupled to the first inflatable balloon to attract the first inflatable balloon to an interior surface of the LAA or to a second inflatable balloon.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of prior U.S. patentapplication Ser. No. 14/941,469, entitled “METHODS AND SYSTEMS FORACCESSING A PERICARDIAL SPACE AND PREVENTING STROKES ARISING FROM THELEFT ATRIAL APPENDAGE,” filed Nov. 13, 2015, which is a continuation ofprior U.S. patent application Ser. No. 13/973,949, entitled “METHODS ANDSYSTEMS FOR ACCESSING A PERICARDIAL SPACE AND PREVENTING STROKES ARISINGFROM THE LEFT ATRIAL APPENDAGE,” filed Aug. 22, 2013, which claims thebenefit and priority under 35 U.S.C. §119(e) of U.S. Provisional PatentApplication No. 61/692,171, entitled “METHODS AND SYSTEMS FOR ACCESSINGA PERICARDIAL SPACE AND PREVENTING STROKES ARISING FROM THE HEART,”filed on Aug. 22, 2012, the entire contents and disclosures of each ofthese applications being hereby incorporated by reference herein; thisapplication is also a continuation-in-part of prior U.S. patentapplication Ser. No. 14/941,457, entitled “APPARATUS AND METHOD FORTREATING BLEEDING ARISING FROM LEFT ATRIAL APPENDAGE,” filed Nov. 13,2015, which is a continuation of prior U.S. patent application Ser. No.13/922,070, entitled “APPARATUS AND METHOD FOR TREATING BLEEDING ARISINGFROM LEFT ATRIAL APPENDAGE,” filed Jun. 19, 2013, which claims thebenefit and priority of U.S. Provisional Patent Application No.61/661,350, entitled “NOVEL TECHNOLOGY FOR TREATING HEMORRHAGE FROM LEFTATRIAL APPENDAGE,” filed on Jun. 19, 2012, the entire contents anddisclosures of each of these applications being hereby incorporated byreference herein.

BACKGROUND

1. Field

Aspects of the present disclosure relate to medical devices and medicalmethods. Specifically, aspects of the present disclosure relate tomethods and systems for accessing a pericardial space and preventingstrokes arising from a left atrial appendage (“LAA”) by achieving acomplete occlusion of the LAA using an epicardial approach withoutcreating a puckering of the LAA ostium.

The LAA is a cylindrical, ear-shaped, and sometimes tortuous andpedunculated muscular pouch projecting from the upper anterior portionof the left atrium of the heart. The LAA is a long, tubular, hookedstructure and has a narrow junction with the venous component of theatrium. Thus, the LAA lies within the pericardial space, and is anextension of the left atrium. The pericardial space is also commonlyknown as the pericardial cavity and thus, both terminologies are usedsynonymously herein. The LAA functions as a decompression chamber duringleft ventricular systole and during periods when left atrial pressure ishigh. The LAA is also commonly known as the left auricular appendix, theauricular, or the left auricle. The left atrium receives oxygenatedblood from the lungs by way of the pulmonary veins, and pumps theoxygenated blood into the left ventricle via the mitral valve. The LAAis more distensible than the rest of the left atrium and for a givenincrease in pressure, expands more than the left atrium. In virtuallyall patients, the LAA has muscle bundles termed pectinate muscles thatare more than 1-mm thick with deep crevices or recesses in-between. Inaddition, in the majority of hearts, distinct protrusions from the LAAbody termed lobes are also present within the LAA. The LAA structure hasreceived increasing attention over the past 15-20 years due to itspropensity to be a site of blood clot formation especially in patientswith atrial fibrillation (“AF”). AF is the most common cause of strokesarising from the heart.

AF patients have a five-fold increased risk of an embolic strokeresulting primarily from thromboembolic events. There is very strongevidence that strokes which occur in AF are thromboembolic, such as, ablood clot which formed in the heart and then breaks off and travels tothe blood vessel in the brain. In non-rheumatic AF patients, thestroke-causing thrombus originates almost exclusively from the LAA.Typically, the thrombus formed in the LAA break away from the LAA andaccumulates in other blood vessels, thereby blocking blood flow in theseblood vessels, and ultimately leading to an embolic stroke.Cardio-embolic strokes related to AF are large and prone to earlyrecurrence with higher mortality. An antithrombotic or anticoagulantdrug is one that suppresses, delays, or nullifies blood coagulation.Treatment with antithrombotic agents, such as warfarin, has been the“cornerstone” of medical therapy for these AF patients, but it can bedifficult to maintain dosage within the therapeutic range andadministration requires frequent monitoring and dose adjustments.Moreover, anticoagulants are associated with undesirable side effects,many of which are exacerbated with advanced age. As high as 50% ofelderly patients are not offered anti-coagulation therapy even thoughthey are at the greatest risk of development of embolic strokes.Therefore, alternative management strategies have been proposed,especially for the elderly, depending on the severity of the condition.

As such, the source of the blood clot must be identified to preventrecurrences and thus provide effective alternative therapy. It has beenestablished that AF-related emboli originate primarily in the LAA. Basedon this knowledge, procedures have been developed where the LAA isobliterated or excised and thus excluded from the systemic circulation.The aim is to prevent or inhibit thrombi in the LAA from embolizing intothe systemic circulation. These procedures include (a) surgeries wherethe LAA is stapled with an amputating stapling device or sutured closedand/or excised and (b) endocardial procedures where an occlusive deviceis placed inside the LAA. Both approaches have been successful and arebeing tested, but also have very significant limitations.

Using stapling and similar technologies to exclude the LAA is oftenassociated with incomplete closure leaving behind a stump. This stumpcan often serve as a source of future embolism. Similarly endocardialdevices also have their share of problems. First, accurate placement ofan endocardial device is highly dependent on the anatomy of the LAA,which is unpredictable because the shape and size of the LAA can varywidely. Other limitations of endocardial devices include the use offixation barbs which can traumatize the LAA wall and incompleteocclusion due to gaps between the endocardial device and the LAA wall.There is also the possibility that the endocardial device may be byitself thrombogenic and it is constantly in contact with left atrialblood. A clip or a suture that is placed outside the heart does not comeinto contact with blood in the LAA cavity, and is less impacted by theLAA anatomy. The novel technology presented in aspects of thisdisclosure allow a puncture from the LAA onto the pericardial space in acontrolled setting without the development of hemorrhage into thepericardial space. Following this, a catheter is exteriorized and overthis, a closure device is inserted via the pericardial space that thenclamps shut the LAA ostium.

Using the same principles described above, of expanding elementsdeployed within the left atrial appendage, it is also possible tocannulate the left atrial appendage from the pericardial space that hasbeen accessed previously using a surgical approach. In doing so,hemostasis is maintained and thus, the approach can be used to create acannula that can be inserted into the left atrium.

2. Description of the Related Art

A number of approaches for plugging the LAA with an implantable devicedelivered via an endovascular approach have been proposed. Inparticular, occlusion of the LAA is believed to decrease the risk of anembolic stroke in non-valvular AF patients. By occluding the LAA, thethrombus formed in the LAA are unable to migrate to other blood vessels,thereby reducing the risks of thromboembolism and embolic stroke. Hence,the occlusion of the LAA is believed to be an effective strokeprevention strategy in non-valvular AF patients. Indeed, this concept ofoccluding the LAA as a stroke prevention strategy is being increasinglytested with implantable medical devices that occlude the LAA using anendocardial and epicardial approaches.

An example of an endocardial approach is the WATCHMAN device developedby Atritech Inc. (located in Plymouth, Minn.). The WATCHMAN device is animplantable device designed to occlude the LAA in non-valvular AFpatients. The WATCHMAN device is delivered to the LAA via anendovascular approach and is placed distal to the LAA ostium, which uponexpansion, occludes the LAA. The occlusion of the LAA prevents themigration of the thrombus formed in the LAA, thereby reducing the risksof thromboembolism and embolic stroke. In the WATCHMAN device's clinicaltrial, PROTECT-AF, the results showed that in AF patients who werecandidates for warfarin therapy, the closure of the LAA using theWATCHMAN device was associated with a reduction in hemorrhagic strokerisk as compared to warfarin therapy. Additionally, these results showedthat all-cause stroke and all-cause mortality outcomes were non-inferiorto warfarin.

However, the WATCHMAN device's “one size or one shape fits all” approachresults in several limitations, such as inadequate circulatory exclusionof the LAA. For example, a major limitation of the WATCHMAN device isthe incomplete occlusion of the LAA because it is relatively common forthere to be a gap between the WATCHMAN device surface and the LAA wall.These gaps are more likely to enlarge over time and persist, while newgaps also occur during follow up. Gaps are also commonly noted toenlarge over time, and new gaps occur during follow up even if the LAAwas completely sealed at implantation. The long, tortuous andpedunculated structure of the LAA can make it difficult to seat thedevice within the LAA cavity. This can result in the device placed in asuboptimal manner with incomplete occlusion, and an incomplete occlusionis worse than no occlusion. Aspects of the present disclosure providefor more refined systems and methods for achieving a complete occlusionof the LAA.

Another limitation of the WATCHMAN device is the fixation of barbs orwires engaged in the walls of the LAA. As shown in the WATCHMAN device'sPROTECT-AF trial, major adverse events include bleeding and pericardialeffusion. Pericardial effusion is the abnormal accumulation of fluid inthe pericardial cavity, which can negatively affect heart function.Aspects of the present disclosure provide for more refined systems andmethods for achieving a complete occlusion of the LAA without the risksassociated with tears or bleeding arising from the fixation of barbs orwires engaged in the LAA walls and without implanted hardware that isconstantly exposed to blood in the LAA cavity.

More recently, EpiTek Inc. (located in Bloomington, Minn.) andSentreHEART, Inc. (located in Redwood City, Calif.) have each developedimplantable devices designed to occlude the LAA. The SentreHEART, Inc.'sdevice is called the LARIAT. These devices are introduced percutaneouslyinto the pericardial cavity, also known as the pericardial space, andthen used to place a suture circumferentially at the ostium of the LAA,typically referred to as LAA ligation. Pericardial access is typicallyestablished via a subxiphoid approach with a needle. A wire is placedthrough the needle into the pericardial cavity. A sheath is then placedin the pericardial space through which a catheter is advanced to thedesired location. The procedure of obtaining pericardial access with aneedle via a subxiphoid approach can be technically difficult, andassociated complications include lacerations of the myocardium, thecoronary arteries and veins. Unlike the Epitek device, the LARIAT devicealso involves placement of a balloon within the LAA. Using magneticforces, the wire within the pericardial space and the balloon in the LAAare made to come into contact. A pre-tied suture that is placed aroundthe LAA is advanced from the exterior over the wire and balloon and thentightened. Due to the severe technical limitations associated with theprocedure, it has not been adopted in a widespread manner. Aspects ofthe present disclosure provide for an anchoring hemostatic mechanismthat makes the procedure of accessing the pericardial space safer andless difficult.

LAA ligation from a circumferentially applied suture or tie also suffersfrom puckering of the occlusion which can compromise sealing. Inaddition to causing a puckering and incomplete occlusion of the LAAostium, a circumferential suture also has the disadvantage of having apotential to cause a tear or laceration of the LAA. It is anticipatedthat in the elderly hearts (the elderly patients are the primarycandidates of this approach), which are known to be delicate, thisapproach may be associated with an even greater risk of bleeding andtears. In the event of a tear of the LAA in the elderly hearts, there isa high likelihood of this being fatal. This is an emergent situation andthere will not be time to transfer the patient to the operating room.Aspects of the present disclosure provide for more refined systems andmethods for achieving a complete occlusion of the LAA without creating apuckering effect.

For the foregoing reasons, there is a need for novel technology toachieve a complete occlusion of the LAA without creating a puckering ofthe LAA ostium. Aspects of the present disclosure address this need bypresenting methods and systems for achieving a complete occlusion of theLAA using an epicardial approach without creating a puckering of the LAAostium.

Additionally, within the last decade, there has been an increasing useof a surgically deployable metallic clip that can be place around thebase of the LAA. The most prominent among these is the AtriClipmanufactured by AtriCure Inc. (located in Cincinnati, Ohio) described inU.S. Patent Application Nos. 2006/027553 and 2009/051270. The AtriClipis made of two parallel rigid titanium tubes with elastic nitinolsprings covered with a knit-braided polyester sheath. Deploying theAtriClip is a surgical procedure that requires the chest in between theribs to be cut open rather than a puncture and is placed over the LAAunder direct visualization. It is not a minimally invasive procedurethat is necessarily performed by the surgeon rather than thecardiologist.

Methods and apparatus for accessing a pericardial space and optionallyplacing an external closure over the LAA are described in U.S. Pat. No.6,423,051; U.S. Pat. No. 7,951,069; and U.S. Patent Application No.2011/276,075 (“the '075 application”).

Aspects of the present disclosure are distinguished from theaforementioned references for at least the following reasons. Inparticular, the '075 application only discloses a single occlusionmember to occlude the LAA that is then followed by an intentionalperforation of the LAA to obtain access to the pericardial space. Thecatheter is then exteriorized and using the exteriorized catheter as arailing, a suture is delivered to ligate the LAA. Moreover, the '075application only discloses an occlusion member inflated within the LAA,in which this one inflated balloon is used to occlude the entirety ofthe LAA cavity. By contrast, a focus of the current disclosure is tolimit or eliminate blood flow through the neck-like ostium of the LAA.This is achieved by the expansion of a plurality of inflatable balloonsimmediately across the LAA ostium both within the LAA and in the leftatrial cavity. The LAA wall has thick muscle bundles that are more than1-mm thick with deep recesses in-between the bundles, giving it a roughappearance. Protrusions from the LAA wall termed lobes are also seen inthe majority of the hearts. Due to these recesses and lobes, a singleocclusion member within the LAA cavity is unlikely to provide aneffective hemostatic seal. By contrast, aspects of the presentdisclosure provide a plurality of inflatable balloons to provide aneffective hemostatic seal.

In aspects of the present disclosure, the main occluding element isdeployed within the cavity of the left atrium, rather than within theLAA. This main occluding element, such as an inflatable balloon, hasdimensions larger than the LAA ostium when inflated. Thus, wheninflated, this main occluding element envelops the LAA ostium. This mainoccluding element's surface is in contact with the smooth surface of theleft atrial cavity wall and upon full deployment, is able to provide aneffective hemostatic seal.

The primary purpose of the expandable elements that are within the LAA,rather than to achieve a hemostatic seal, is to pull the left atriumcavity balloon towards the LAA ostium (by application of electromagneticor magnetic forces) and to jam it shut. In an exemplary embodiment, thepresent disclosure includes the presence of thin tubes attached to theballoon surface of the left atrium cavity balloon. These tubes allow forthe application of vacuum or suction forces that will be applied againstthe smooth-walled left atrium to allow for a more effective hemostaticseal.

The use of multiple inflatable balloons to create a tight hemostaticseal for occluding the LAA ostium is not presented in the prior art. Inparticular, at least one of the inflatable balloons occluding the LAAostium is non-compliant, such that upon inflation of the non-compliantballoon, the surrounding LAA walls are expanded to accentuate theconstriction that one would expect at the LAA ostium. The use of thesemultiple inflatable balloons distinguishes aspects of the presentdisclosure from the prior art's single occlusion element that is placedwithin the LAA cavity. Hence, embodiments of the present disclosureshould not result in gaps between the occlusion element's surface andthe LAA walls. Second, the use of electromagnetic or magnetic coilswithin the inflatable balloons, wherein upon inflation of theseballoons, the electromagnetic or magnetic coils also expand within theseballoons, is not present in the prior art. These electromagnetic coilsfurther enhance the hemostatic seal by way of magnetic orelectromagnetic forces between the inflated balloons occluding the LAAostium. The use of the electromagnetic coils ensures that embodiments ofthe present disclosure do not result in gaps between the occlusionelement's surface and the LAA walls.

Another novel feature of aspects of the present disclosure is thecoating of the inflatable balloons with biocompatible hydrogels toprovide a superior seal. Also novel is the presence of tubules attachedprimarily to the left atrial cavity balloon will allow for the vacuum orsuction forces that are applied from an external source. This willresult in the left atrial and LAA tissues adhering to the balloons moreeffectively, thus resulting in a superior seal.

Embodiments of the present disclosure including a closure devicecomprising a suture looped around two semi-rigid tubes furtherdistinguishes aspects of the present disclosure from the prior art. Thepresent disclosure's closure device ensures that there shall be nopuckering effect around the LAA ostium commonly seen in the prior art,such as with the devices developed by EpiTek Inc. and SentreHEART, Inc.Additionally, the coating of hydrogel or silicone to the interiorsurfaces of the two semi-rigid tubes is another novel feature, ensuringthat there is no puckering effect. Moreover, an anchoring balloonattached to the exteriorized catheter used to stabilize the LAA whilethe closure device is being deployed to the LAA ostium is yet anotherdistinguishing novel feature. This anchoring mechanism ensures that theexteriorized catheter, when pulled externally is able to have itsproximal end within the LAA cavity, after the hemostatic balloons havebeen deflated and removed. Furthermore, aspects of the presentdisclosure provide for an injuring step that is not present in the priorart. Specifically, the injury step is designed to induce to induce atissue response that enhances the closure and sealing of the LAA ostium.

Embodiments of the present disclosure can also be used for otherpurposes to canulate the pericardial cavity. In case it is decided tonot occlude the LAA ostium at the end of the procedure, the site ofpuncture in LAA can be sutured closed with an absorbable ornon-absorbable suture (with or without a collagen pledget) applied fromthe exterior.

It is also anticipated that embodiments of the present disclosure can beused to occlude or ligate any tubular structure (vascular or otherwise)within the body (for example an aneurysm).

Using the same principles described above, of expanding elementsdeployed within the left atrial appendage, it is also possible tocannulate the left atrial appendage from the pericardial space that hasbeen accessed previously using a surgical approach. In doing so, andusing a device that allows for the application of “counter-pressure,”hemostasis is maintained and thus, the approach can be used to create acannula that can be inserted into the left atrium.

Underlying Principles of Aspects of the Present Disclosure

Unlike the right atrial appendage which has a broad based pyramidalshape, the cylindrical pedunculated shape of the LAA and the presence ofa narrow waist or constriction at the LAA ostium allows this structureto be occluded by the placement of expanding elements within or adjacentto the LAA. The LAA is also more compliant compared to the left atrialcavity allowing for balloons to be inflated within the LAA.

Occluding the LAA allows for the controlled puncture of the LAA whereaccess to the pericardium can be obtained from the left atrial cavity,without any bleeding occurring into the pericardial space. The catheterthat is placed in the pericardium can now puncture the parietalpericardium and be exteriorized for example in the subxiphoid region.This can be used to deliver materials and devices to the pericardialspace in a safe manner.

However, inflating a cylindrical balloon solely within the LAA isunlikely to provide a safe and stable hemostatic occlusive seal for thefollowing reasons. The first reason is the presence of pectinate musclesand lobes in the LAA. Nearly all adult LAAs contain pectinate musclesthat are greater than 1-mm in diameter. As a result of these pectinatemuscles, the LAA has a rough quality unlike the left atrial cavity,which is smooth-walled. Deep recesses are present in the LAA in-betweenthese pectinate muscles. The LAA also has the presence of largerdistinct protrusions termed lobes. The presence of these lobes andrecesses makes it difficult for a single balloon inflated within the LAAto provide an effective seal since the cavity of the lobes and therecesses would allow for blood through flow through.

In some hearts, a distinct constriction is absent at the ostium of theLAA. In some atria, the constriction when present at the LAA ostium isnot circumferential. This raises the possibility that upon inflation ofa single balloon within the LAA, this inflated balloon may fall out ofthe LAA into the left atrial cavity.

Aspects of the novel disclosure presented in this application solve theabove mentioned problems through the following innovations illustratedby the hour-glass concept.

The Hour-Glass Concept.

The Hour-Glass concept presents the importance of multiple inflatableballoons in controlling the neck of the hour-glass. One of the keyfactors affecting the time measured in the hour-glass is the neck width.The neck of the hour-glass represents the LAA ostium. The top bulb ofthe hour-glass represents the left atrial cavity while the bottom bulbof the house-glass represents the LAA. This hour-glass concept as itrelates to the LAA was conceived by the named inventor on this patentapplication.

Aspects of the present disclosure are based on the concept thatpreventing the sand or water flowing from the top bulb to the bottom,which is achieved by occluding or sandwiching the neck by a combinationof inflatable balloons that are deployed across the constriction andforced towards each other rather by inflating a single balloon in thebottom bulb only. These inflatable balloons that are placed immediatelyacross the neck are approximated towards each other by a combination ofpushing and pulling, as detailed in FIGS. 17-18. A first balloon isinflated within the LAA adjacent to the LAA ostium and a second balloonis inflated within the distal portions of the LAA. The inflated secondballoon pushes the inflated first balloon towards the neck of thehour-glass, which represents the LAA ostium. The inflated first balloonis also pulled towards the neck of the hour-glass by manual traction onthe inner sheath.

A third balloon is inflated within the left atrial cavity adjacent tothe LAA ostium. Electromagnetic coils can also be present within thefirst and the third balloon. The electromagnetic coils in the inflatedthird balloon also pull the inflated first balloon towards the neck ofthe hour-glass by way of electromagnetic forces. Conversely, theelectromagnetic coils in the inflated first balloon pull the inflatedthird balloon towards the neck of the hour-glass by way ofelectromagnetic or magnetic forces. Thus, the main function of theinflated first balloon is to pull the inflated third balloon towards theLAA ostium by way of electromagnetic forces. The main function of theinflated second balloon is the push the inflated first balloon towardsthe LAA ostium.

Aspects of the present disclosure present the accentuation orexaggeration of the LAA ostium by inflating a non-compliant balloonwithin the LAA adjacent to the LAA ostium. The first inflatable balloonis non-compliant and inflated with higher pressure. A non-compliantballoon is likely to deform the LAA walls and by creating expanding theLAA walls, it will accentuate the neck of the hour-glass and allow for abetter approximation of the inflated balloons against the surfaces.(Hoit B D, Walsh R: Regional atrial distensibility. American Journal ofPhysiology 1992; 262:H1356-H1360). The LAA is more distensible than theleft atrial cavity and hence should readily deform especially inresponse to high pressure inflation with a non-compliant balloon. Theinflated non-compliant first balloon is then forced towards the LAAostium by a combination of pushing and pulling.

The second balloon is largely compliant and is inflated within thedistal portion of the LAA. Upon inflation, the second balloon conformsto the LAA anatomy and pushes the inflated first balloon further towardsthe LAA ostium, as shown on FIGS. 17-18. Additionally, the inflatedsecond balloon prevents the inflated first balloon from being pushedaway from the LAA ostium.

The third balloon, which is located on the outer sheath, is inflatedwithin the left atrial cavity adjacent to the LAA ostium and is pushedtowards the LAA ostium. Thus, the inflated third balloon envelops theLAA ostium. The inflated first and third balloons are manually pushedtowards each other by pulling on the inner sheath and pushing on theouter sheath.

Aspects of the present disclosure guard against the possibility of theinflated first balloon falling out of the LAA and into the left atrialcavity. In particular, the inflated third balloon has an additionalfunction of preventing the inflated first balloon from falling into theleft atrial cavity especially in the setting of an indistinct LAA ostiumwhere a constriction is absent. Additionally, a locking mechanism isdescribed where the inner and outer sheaths lock on to each other. Thislocking mechanism may be present intravascular, intracardiac, or outsidethe body. In addition, an additional inflatable balloon that is attachedto the outer sheath can be inflated immediately to the left of theinteratrial septum to render the outer sheath stationary.

The LAA ostium has an oval shape. Applying a circumferential tie orsuture to the LAA ostium is going to compress a fixed circumference to asmaller area and therefore will cause puckering. Puckering is morelikely to cause gaps and incomplete occlusion. A suture is also morelikely to cause tears in the LAA especially in elderly hearts. A closuredevice that approximates the opposing surfaces is a better approach andis unlikely to cause puckering. Embodiments of the present disclosurepresent a novel closure device that approximates surfaces opposite toeach other and brings them into contact is a better approach. This ismost effectively created by applying forces along the short axis orshort diameter of the oval or elliptical ostium. Hence, a barrette orclip applied at the ostium of the LAA is more likely to seal off thestructure. Force applied along the long diameter is less likely toapproximate the opposite surfaces since (a) the two surfaces will haveto travel a longer distance and (b) a greater amount of force will benecessary to overcome the intrinsic tissue elasticity.

Creating endothelial denudation at the LAA ostium by intentional injurywill create inflammation and cross-linking of collagen fibers, resultingin more durable occlusion of the LAA ostium. Aspects of the presentdisclosure provide such a feature. For example, endothelial denudationat the LAA ostium can be created by application radiofrequency (RF)current via the inflatable balloons at the LAA ostium.

The Concept of Counter-Pressure.

A logical extension of the above methods is whether the same concept andmethod can also be used to penetrate the LAA and place a conduit intothe structure to allow for various interventions performed on the heart.In this situation, the LAA is pierced in the opposite direction, i.e.from the pericardial space that has been accessed previously using asurgical approach. The cannula that is inserted into the LAA has anexpandable element such as a balloon with suction or magnetic orelectromagnetic elements attached to its wall.

With epicardial surgical cannulation of the LA appendage and asubsequent inflation of a balloon within the LA appendage, a system ofmultiple balloons or expanding elements that adhere to each other withone balloon inflated within the left atrial cavity (and thus trying toachieve a tight seal across the ostium of the appendage) may not benecessary. This may be because since the operator has ready access tothe pericardial cavity and the epicardial surface of the left atriumappendage, after inflating the balloon, pressure can be applied with aconstricting device or loop from the epicardical surface. Or,“counter-pressure” can be applied in a circumferential manner from anouter sheath. The term counter-pressure refers to pressure applied inone direction to counter balance pressure from another. Hence, the wallof the left atrial appendage may be compressed in a circumferentialmanner from both the endocardial and epicardial directions.

The wall of the LAA tends to be extremely thin. While attempting topierce this wall, the wall may invaginate. The subsequent puncture maytherefore occur in an oblique fashion and may result in a tear orlaceration rather than a focused and sharply limited perforation. Inorder to cannulate the wall, it is critical to hold it fixed and preventinvagination during piercing of the structure. It is preferable thatperforation of the structure occur perpendicular to the left atrial wallrather than in an oblique manner. To facilitate this, the piercingelement may be inserted through a tube and attached to the circumferenceof this outer tube, may be a plurality of suction elements. In apreferred embodiment, no suction will be applied through the main lumenof the tube via which the piercing element is advanced.

SUMMARY OF THE DISCLOSURE

Aspects of the present disclosure address the foregoing needs with novelmethods and systems for accessing a pericardial space and preventingstrokes arising from the LAA by achieving a complete occlusion of theLAA using an epicardial approach without creating a puckering of the LAAostium. The contents of this summary section are provided only as asimplified introduction to the disclosure, and are not intended to beused to limit the scope of the appended claims.

In an exemplary embodiment, the present disclosure includes a systemcomprising a catheter having an inner sheath, an outer sheath, and aninner catheter; the inner sheath having a distal end and a proximal end,wherein the distal end has at least two inflatable balloons; the outersheath having a distal end and a proximal end, wherein the distal endhas at least one inflatable balloon; the inner catheter having a distalend and a proximal end, wherein the distal end has a tissue-penetratingtip, and wherein the proximal end has at least one inflatable balloonserving as an anchor; locking means to lock the inner sheath and theouter sheath; an inflation port; a control port; and a closure devicehaving a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons; the outer sheath having a distal end and a proximal end,wherein the distal end has at least one inflatable balloon; the innercatheter having a distal end and a proximal end, wherein the distal endhas a tissue-penetrating tip, wherein the tissue-penetrating tip is asharpened tip capable of puncturing (a) a wall of the LAA, and (b) awall of a pericardial cavity, and wherein the proximal end has at leastone inflatable balloon serving as an anchor; locking means to lock theinner sheath and the outer sheath; an inflation port; a control port;and a closure device having a suture looped around at least twosemi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons; the outer sheath having a distal end and a proximal end,wherein the distal end has at least one inflatable balloon; the innercatheter having a distal end and a proximal end, wherein the distal endhas a tissue-penetrating tip, wherein the tissue-penetrating tip is asharpened tip capable of puncturing (a) a wall of the LAA, and (b) awall of a pericardial cavity, wherein the tissue-penetrating tip furtherhas a RF electrode delivering RF current that can puncture (a) a wall ofthe LAA, and (b) a wall of a pericardial cavity, and wherein theproximal end has at least one inflatable balloon serving as an anchor;locking means to lock the inner sheath and the outer sheath; aninflation port; a control port; and a closure device having a suturelooped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons, wherein at least one inflatable balloon of the inner sheathhas a first set of electromagnetic coils or magnetic elements, whereinthe first set of electromagnetic coils expands within the balloon uponinflation of the balloon, and wherein at least one inflatable balloon ofthe outer sheath has a second set of electromagnetic coils, wherein thesecond set of electromagnetic coils expands within the balloon uponinflation of the balloon; the outer sheath having a distal end and aproximal end, wherein the distal end has at least one inflatableballoon; the inner catheter having a distal end and a proximal end,wherein the distal end has a tissue-penetrating tip, and wherein theproximal end has at least one inflatable balloon serving as an anchor;locking means to lock the inner sheath and the outer sheath; aninflation port; a control port; and a closure device having a suturelooped around at least two semi-rigid hollow tubes.

In another exemplary embodiment of the present disclosure, the presentdisclosure includes a system comprising a catheter having an innersheath, an outer sheath, and an inner catheter; the inner sheath havinga distal end and a proximal end, wherein the distal end has at least twoinflatable balloons; the outer sheath having a distal end and a proximalend, wherein the distal end has at least one inflatable balloon; theinner catheter having a distal end and a proximal end, wherein thedistal end has a tissue-penetrating tip, and wherein the proximal endhas at least one inflatable balloon serving as an anchor; locking meansto lock the inner sheath and the outer sheath; an inflation port; acontrol port; and a closure device having a suture looped around atleast two semi-rigid hollow tubes, and wherein the closure devicefurther comprises hydrogel coated over at least an inner surface of thepair of semi-rigid hollow tubes.

In another exemplary embodiment of the inventive system, the presentdisclosure includes a system comprising a catheter having an innersheath, an outer sheath, and an inner catheter; the inner sheath havinga distal end and a proximal end, wherein the distal end has at least twoinflatable balloons; the outer sheath having a distal end and a proximalend, wherein the distal end has at least one inflatable balloon; theinner catheter having a distal end and a proximal end, wherein thedistal end has a tissue-penetrating tip, and wherein the proximal endhas at least one inflatable balloon serving as an anchor; locking meansto lock the inner sheath and the outer sheath; an inflation port; acontrol port; and a closure device having a suture looped around atleast two semi-rigid hollow tubes, and wherein the closure devicefurther comprises silicone gel coated over at least an inner surface ofthe pair of semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons; the outer sheath having a distal end and a proximal end,wherein the distal end has at least two inflatable balloons, wherein atleast one balloon serves as an anchor; the inner catheter having adistal end and a proximal end, wherein the distal end has atissue-penetrating tip, and wherein the proximal end has at least oneinflatable balloon serving as an anchor; locking means to lock the innersheath and the outer sheath; an inflation port; a control port; and aclosure device having a suture looped around at least two semi-rigidhollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons that are coated with biocompatible hydrogel; the outer sheathhaving a distal end and a proximal end, wherein the distal end has atleast one inflatable balloon, wherein at least one balloon serves as ananchor; the inner catheter having a distal end and a proximal end,wherein the distal end has a tissue-penetrating tip, and wherein theproximal end has at least one inflatable balloon serving as an anchor;locking means to lock the inner sheath and the outer sheath; aninflation port; a control port; and a closure device having a suturelooped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons having sponges attached to the exterior of each balloon; theouter sheath having a distal end and a proximal end, wherein the distalend has at least one inflatable balloon, wherein at least one balloonserves as an anchor; the inner catheter having a distal end and aproximal end, wherein the distal end has a tissue-penetrating tip, andwherein the proximal end has at least one inflatable balloon serving asan anchor; locking means to lock the inner sheath and the outer sheath;an inflation port; a control port; and a closure device having a suturelooped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons; the outer sheath having a distal end and a proximal end,wherein the distal end has at least one inflatable balloon havingcaliber tubes attached to the exterior of the balloon, wherein at leastone balloon serves as an anchor; the inner catheter having a distal endand a proximal end, wherein the distal end has a tissue-penetrating tip,and wherein the proximal end has at least one inflatable balloon servingas an anchor; locking means to lock the inner sheath and the outersheath; an inflation port; a control port; and a closure device having asuture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons; the outer sheath having a distal end and a proximal end,wherein the distal end has at least two inflatable balloons, wherein atleast one balloon serves as an anchor, and at least one balloon hascaliber tubes attached to the exterior of the balloon; the innercatheter having a distal end and a proximal end, wherein the distal endhas a tissue-penetrating tip, and wherein the proximal end has at leastone inflatable balloon serving as an anchor; locking means to lock theinner sheath and the outer sheath; an inflation port; a control port;and a closure device having a suture looped around at least twosemi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes asystem comprising a catheter having an inner sheath, an outer sheath,and an inner catheter; the inner sheath having a distal end and aproximal end, wherein the distal end has at least two inflatableballoons and at least one radiopaque marker band; the outer sheathhaving a distal end and a proximal end, wherein the distal end has atleast one inflatable balloon; the inner catheter having a distal end anda proximal end, wherein the distal end has a tissue-penetrating tip,wherein the tissue-penetrating tip, and wherein the proximal end has atleast one inflatable balloon serving as an anchor; locking means to lockthe inner sheath and the outer sheath; an inflation port; a controlport; and a closure device having a suture looped around at least twosemi-rigid hollow tubes.

In an exemplary embodiment, a method of the present disclosure comprisesthe steps of: (1) introducing catheter into a body cavity, the catheterhaving an inner sheath, an outer sheath, and an inner catheter; (2)advancing a distal end of the inner sheath to position the distal end ofthe inner sheath in an interior of an LAA; (3) inflating a firstinflatable balloon, wherein the first balloon is on the distal end ofthe inner sheath, and wherein the first balloon is inflated within theLAA interior adjacent to an ostium of the LAA; (4) pulling the inflatedfirst balloon in a direction from within the LAA interior and towardsthe LAA ostium; (5) inflating a second inflatable balloon, wherein thesecond balloon is on the distal end of the inner sheath, wherein thesecond balloon is inflated within a distal portion of the LAA interior,and wherein upon inflation, the inflated second balloon pushes theinflated first balloon towards the LAA ostium; (6) advancing a distalend of the outer sheath to position the distal end of the outer sheathin a portion of the left atrium adjacent to the LAA ostium; (7)inflating a third inflatable balloon, wherein the third balloon is onthe distal end of the outer sheath, and wherein the third balloon isinflated within a portion of the left atrium adjacent to the LAA ostium;(8) pushing the inflated third balloon in a direction from within theleft atrium portion adjacent to the LAA ostium and towards the LAAostium; (9) activating a locking mechanism to lock the inner sheath tothe outer sheath, thereby rendering stationary the inflated balloons;(10) advancing a distal end of the inner catheter to position a distalend of the inner catheter within a distal portion of the LAA interiornear an apex of the LAA; (11) puncturing a wall of the LAA interior nearor at the LAA apex using a tissue-penetrating tip on the distal end ofthe inner catheter; (12) advancing the distal end of the inner catheterinto the pericardial cavity and through the pericardial cavity to thedesired site of exteriorization; (13) puncturing a wall of thepericardial cavity at the desired site of exteriorization; (14)externalizing the inner catheter out of the pericardial cavity at thedesired site of exteriorization, wherein the inner catheter can beexternalized or “pushed out” with a combination of manual force,electromagnetic force, and/or radio frequency energy delivery; (15)advancing a proximal end of the inner catheter to the distal portion ofthe LAA interior near the LAA apex; (16) inflating a fourth inflatableballoon, wherein the fourth balloon is on the proximal end of the innercatheter, and wherein the fourth balloon is inflated within the distalportion of the LAA interior near the LAA apex; (17) pulling the inflatedfourth balloon in a direction from within the distal portion of the LAAinterior near the LAA apex and towards the pericardial cavity to anchorthe LAA; (18) advancing an LAA closure device to the LAA ostium via theexternalized inner catheter and positioning the LAA closure device overthe exterior of the LAA ostium; (19) deploying the LAA closure deviceover the exterior of the LAA ostium; and (20) injuring at least aportion of an interior surface of the LAA ostium to promote occlusion ofthe LAA.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At steps (3) and (7), the first and thirdinflatable balloons each have a set of electromagnetic coils or magneticelements located within. Upon inflation of these balloons, therespective sets of electromagnetic coils also expand within therespective balloon. The expansion of the electromagnetic coils createselectromagnetic forces that attract the first and third inflatedballoons towards each other.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At steps (3) and (5), the first and secondinflatable balloons have biocompatible hydrogel coated to the exteriorof each balloon. Upon inflation of these balloons, the biocompatiblehydrogel expands on contact with fluid, such as blood.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At step (7), the third inflatable balloon hascaliber tubes attached to its exterior. These tubes will allow for theapplication of vacuum or suction forces to the left atrial tissue or tothe surface of the adjacent balloon to provide for a tighter hemostaticseal.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At steps (11) and (13), the tissue-penetrating tipis a sharpened tip capable of puncturing (a) the wall of the LAA, and(b) the wall of the pericardial cavity. The penetrating tip may furthercomprise a RF electrode delivering RF current sufficient to puncture (a)the wall of the LAA, and (b) the wall of the pericardial cavity.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At steps (12) to (14), the desired site ofexteriorization is at the junction of the abdomen and thorax and belowthe ribs near a base of the sternum called a xiphisterum so that theinner catheter follows a subxiphoid path.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At steps (12) to (14), the desired site ofexteriorization is at the junction of the abdomen and thorax and belowthe ribs near a base of the sternum called a xiphisterum so that theinner catheter follows a subxiphoid path. In other exemplaryembodiments, the desired sites of exteriorization include the rightpectoral regions, the left pectoral regions, or any other region higherup in the chest, lateral to the sternum between the ribs.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At step (14), the inner catheter can be “pulledout” from the pericardial cavity with electromagnetic forces appliedwith another catheter having an electromagnetic probe that is placed atthe desired site of exteriorization. A small incision can be made in theskin to the left of the xiphisternum, or higher up in the chest, forexample, lateral to the sternum between the ribs. An electromagneticprobe is introduced towards the pericardial cavity through this incisionto attract the inner catheter (that has electromagnets incorporated)that is then exteriorized. The distal end of the inner catheter wouldcomprise an electromagnetic element, which interacts with theelectromagnetic probe adapted to draw the inner catheter out of thepericardial cavity.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. At step (19), the closure device may be coated overat least an inner surface with a hydrogel, silicone gel, and/or otherbiocompatible material. Hydrogels will expand on contact with fluid,such water or blood, to further compress the LAA ostium.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. Between steps (08) and (09) is an additional step,wherein this step includes inflating an additional balloon within aportion of the left atrium adjacent to the interatrial septum to renderstationary the outer sheath. This additional balloon is on the distalend of the inner sheath and serves to anchor in-place the outer sheathand the other inflated balloons. Alternatively, this additional ballooncan inflated adjacent the fossa ovalis. Optionally, a locking mechanismcan be activated to render stationary the outer sheath and this inflatedadditional balloon adjacent to the interatrial septum. This lockingmechanism can be deployed after the inflation of this additional balloonbut before step (09). The locking mechanism would be similar to the onedeployed in step (09).

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. For brevity, steps (1)-(20) ofthe exemplary embodiment of the present disclosure's method areincorporated herein. After step (20), this alternate exemplaryembodiment further includes the steps of: deflating the first inflatedballoon, deflating the second inflated balloon, deflating the thirdinflated balloon, deactivating the locking mechanism, removing the outersheath from the body cavity, and removing the inner sheath from the bodycavity.

In another exemplary embodiment, a method of the present disclosurefurther comprises the following features. Unlike the method describedabove, the LAA is pierced in the opposite direction, i.e. from thepericardial space that has been accessed previously using a surgicalapproach (as shown in FIGS. 21-30), to safely insert a cannula orconduit into the heart via the LAA. FIGS. 22 and 23 show an insertion ofa plurality of hollow tubes where an inner and outer tubes can slideover each other. Inflatable balloons are attached to these tubes. Theballoons may be inflated in such a way that one balloon is inflatedwithin the left atrial cavity while the other is inflated within theLAA. The sheaths are then slid over each other so that the balloons arenow pulled towards each other. In addition, the balloons are attractedtowards each other to produce a seal of the LAA ostium using magnetic,electromagnetic or suction forces. Thus, the tube inserted into the LAAserves as a conduit through which any additional tools or materials canbe inserted into the heart.

In another exemplary embodiment, a method of the present disclosurecomprises the following features. The wall of the LAA tends to beextremely thin. While attempting to pierce this wall, the wall mayinvaginate (seen as a dashed line in FIG. 24). The subsequent puncturemay therefore, may occur in an oblique fashion and may result in a tearor a laceration rather than as a focused and sharply limitedperforation. In order to pierce the wall optimally, it is critical tohold it fixed and prevent invagination during piercing of the structure(the taut and fixed LAA wall is shown as 2504 in FIG. 27A). FIG. 25shows a suction cannula that applies suction to the LAA wall with apiercing element that is within the suction cannula. In this exemplaryembodiment, it is preferable that perforation of the structure occurperpendicular to the left atrial wall rather than in an oblique manner.However, the design shown in FIG. 25 may be problematic. The thin wallof the appendage may get sucked into the cannula in the form or anipple, bleb or bubble. The wall may get pierced in an oblique andsuboptimal fashion. To facilitate a focused puncture rather than a tearor a laceration, the piercing element will inserted through a tube andattached to the circumference of this outer tube, will be a plurality ofsuction elements (shown in FIGS. 27A-C) which will keep the LAA walltaut (2504 in FIG. 27A) and prevent it from getting sucked into the tubethat houses the piercing element. In a preferred embodiment, no suctionwill be applied through the main lumen of the tube (2708) via which thepiercing element (2102) is advanced. It is also expected that thesurface of the balloon upon inflation within the LAA (seen as 2802 inFIGS. 28; 2904 and 2906 in FIG. 29; and as 3002 in FIG. 30) will havetubes attached to it to apply suction.

FIG. 26 represents an outer sheath that will be used to providecounter-pressure. Application of counter-pressure where the inflatedballoon within the LAA is pulled back while the outer sheath is pushedforward, is described in greater detail in regard to FIGS. 28 and 29. Asuction device includes a sheath 2602 that extends over the suction tube2502 and has a greater diameter and will be advanced forward towards theLAA as the tip is pulled back by suction forces applied by the suctionapplication tube. The sheath 2602 may include an end 2510 that isconfigured to be placed against the outer surface of the LAA 2406 toapply the suction force. The additional diameter of the sheath 2602 byenveloping the puncture may provide for additional control of the LAAduring puncture by the tip 2402.

The embodiments shown in FIGS. 25-27 may provide for additional controlof the LAA wall during puncture of the LAA, and reduction of undesiredtearing or laceration of the structure and bleeding of the LAA. Thesystems and methods disclosed in regard to FIGS. 25-27 may beincorporated into any system or method disclosed in this application orin U.S. patent application Ser. No. 14/941,457.

In another exemplary embodiment, a method of the present disclosurecomprises the following features. The cannula that is inserted into theLAA has an expandable element such as a balloon with suction or magneticor electromagnetic elements attached to its wall.

With epicardial surgical cannulation of the LA appendage and asubsequent inflation of a balloon within the LA appendage, a system ofmultiple balloons or expanding elements that adhere to each other withone balloon inflated within the left atrial cavity (and thus trying toachieve a tight seal across the ostium of the appendage) may not benecessary. This is because since the operator has ready access to thepericardial cavity and epicardial surface of the left atrium appendage,after inflating the balloon, pressure can be applied with a constrictingdevice or loop from the epicardial surface. Or, “counter-pressure” canbe applied in a circumferential manner from an outer sheath. The termcounter-pressure refers to pressure applied in one direction to counterbalance pressure from another. Hence, the wall of the left atrialappendage may be compressed in a circumferential manner from both theendocardial and epicardial directions. The endocardial pressure will beapplied by the inflated balloon that after inflation, is pulledbackwards towards the point of entry (shown in FIGS. 28 and 29). FIG. 28illustrates an embodiment of the present disclosure in which aninflatable balloon 2802 is inflated within a cavity of the LAA 2406. Theinflatable balloon 2802, upon inflation and pulling back towards theentry point, may apply pressure against an interior or endocardialsurface of the LAA. The pressure applied by the inflatable balloon 2802may be applied in a direction towards the exterior of the LAA.Similarly, in FIG. 29, the balloon that has a strawberry shape (2904 and2906) is inflated and is pulled back towards the entry point. Thepressure applied by the inflatable balloon may be provided by thepressure of inflation, or may be provided by a force caused by thesheath 2804 being drawn in a direction towards the exterior of the LAA.A pressure applicator device that applies pressure on the outer orepicardial surface is shown as 2808 in FIG. 28 and as 2908 in FIG. 29.The epicardial pressure applicator may be used to apply pressure to theLAA in a direction opposite to the pressure applied by the inflatableballoons. The pressure applicator device 2808 may be pushed towards theLAA wall. The pressure applicator device 2808 may comprise a sleeve orother form of pressure applicator device that is configured to applypressure to the outer surface of the LAA. In the embodiment shown inFIG. 28, the pressure applicator device 2808 may have a funnel shapeconfigured to contour to the shape of the LAA. The funnel shape mayincrease the area over which pressure is applied. In one embodiment, thepressure applicator device, and/or the inflatable balloon may haveshapes that complement each other as shown in FIG. 29. For example, inone embodiment, the inflatable balloon may have a conical shape and thepressure applicator device may have a funnel shape.

The pressure applicator device 2808 may be coupled or attached to thesheath 2804. A locking mechanism 2810, such as a spring lockingmechanism disclosed in this application may be used to maintain theforces provided by both the inflatable balloon 2802 and the pressureapplicator device 2808. The locking mechanism 2810 may be used to holdand lock the inflatable balloon and the pressure applicator device inposition relative to each other.

The pressures applied by the inflatable balloon 2802 and the pressureapplicator device 2802 may comprise counter-pressures. The pressures areapplied in opposite directions and thus counter balance each other. Thecompressive force may serve to seal the LAA ostium, and/or preventbleeding from the wall of the LAA.

As shown in FIGS. 28 and 29, a pressure may be applied to both sides ofthe LAA, in a circumferential manner, near the puncture site. Hemostasismay be desirably maintained effectively within the LAA. FIG. 29illustrates an embodiment of a pressure being applied by an inflatableballoon 2902 in a similar manner as disclosed in regard to theembodiment of FIG. 28. The LAA is entered from a surgically accessedexterior/pericardial space. The inflatable balloon 2902, however, has afirst portion 2904 and a second portion 2906. The first portion 2904 mayhave a different degree of compliance than the second portion 2906 andhas a wider diameter.

The pressure applicator device 2908 in FIG. 29 may have a funnel shapeto complement the conical shape of the second portion of the expandingelement 2906. The pressure applicator device 2908 may be pressed againstthe outer surface of the LAA wall, and the inflatable balloon may beinflated to provide a pressure against the inner surface of the LAAwall, or may be drawn towards the inner surface of the LAA wall. Aneffective counter pressure may be provided in the embodiment of FIG. 29that is achieved over a larger area than shown in regard to theembodiment of FIG. 28. To increase the effectiveness of preventingbleeding across the entry site, the inflatable balloon may have suctiontubes along its inflated surface to improve adhesion of the balloonsurface with the endocardial wall of the LAA.

In another exemplary embodiment, a method of the present disclosurecomprises the following features. FIG. 30 shows an example ofcounter-pressure where the epicardial pressure is exertedcircumferentially in a constricting manner along a preselected zone. Inthis embodiment, epicardial pressure is not exerted around the entrysite of the LAA. In this Figure, inflatable balloon 3002 is inflatedwithin a cavity of the LAA 2406. The LAA is entered from a surgicallyaccessed exterior/pericardial space. The inflatable balloon 3002 may becoupled to a sheath 3004. The inflatable balloon 3002 may include anindentation 3006. The indentation 3006 may have the form of a groovethat extends circumferentially around the balloon 3002. The indentation3006 may be pre-formed into the inflatable balloon 3002 and serves toprevent the circumferential tie or constriction from dislodging.

In another exemplary embodiment, a method of the present disclosurecomprises the following features. FIG. 31 illustrates an embodiment ofthe present disclosure in which suction devices are utilized with one ormore of the inflatable balloons 102, 104, 115. The suction devices maytake the form of tubes 3102 that are coupled to one or more of theinflatable balloons 102, 104, 115. The suction devices may be configuredto provide a suction force. The suction force may be used to attract anyof the balloons 102, 104, 115 to each other, or may be used to attractany of the balloons to an interior surface of the LAA. In oneembodiment, the suction devices may be used as a substitute for theelectromagnetic coils disclosed in this application.

BRIEF DESCRIPTION OF THE DRAWINGS

Other systems, methods, features and advantages of the presentdisclosure will be, or will become, apparent to one of ordinary skill inthe art upon examination of the following figures and detaileddescription. It is intended that all such additional apparatuses,systems, methods, features and advantages be included within thisdescription, be within the scope of the present disclosure, and beprotected by the appended claims. Component parts shown in the drawingsare not necessarily to scale, and may be exaggerated to betterillustrate the important features of the present disclosure. In thedrawings, like reference numerals designate like parts throughout thedifferent views, wherein:

FIG. 1 is a perspective view of an exemplary embodiment of a catheter,which is part of present disclosure's system for accessing a pericardialspace and preventing strokes arising from the LAA.

FIG. 2 is a perspective view of the locking means of the exemplaryembodiment of FIG. 1.

FIG. 3 is a flowchart depicting an exemplary embodiment of the presentdisclosure's method for accessing a pericardial space and preventingstrokes arising from the LAA.

FIG. 4 is a first perspective view depicting the initial steps of theexemplary embodiment of FIG. 3.

FIG. 5 is a second perspective view depicting the initial steps of theexemplary embodiment of FIG. 3.

FIG. 6 is a third perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 6illustrates the advancement of the inner catheter through the wall ofthe LAA and into the pericardial cavity surrounding the heart.

FIG. 7 is a fourth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 7illustrates the further advancement of the inner catheter through thepericardial cavity and into a region adjacent to the xiphisternum.

FIG. 8A is a fifth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 8Aillustrates the inner catheter being “pulled out” and exteriorized byway of electromagnetic forces.

FIG. 8B illustrates alternative sites for exteriorizing the innercatheter after it has been drawn from the pericardial cavity.

FIG. 9 is a sixth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 9 shows thedeployment of the closure device being advanced over the exteriorizedinner catheter and to the exterior of the LAA ostium.

FIG. 10 illustrates a prior art closure device employing a loop orsuture which results in puckering of the LAA ostium.

FIG. 11 is a seventh perspective view depicting the intermediate stepsof the exemplary embodiment of FIG. 3, and in particular, FIG. 9illustrates the deployment of the closure device being deployed over theexterior of the LAA ostium without creating a puckering of the LAAostium.

FIG. 12 is an eighth perspective view depicting the intermediate stepsof the exemplary embodiment of FIG. 3, and in particular, FIG. 12illustrates the injury of the inner surface of the LAA prior to closure,where the injury causes an injury response which results in a morecomplete sealing along the opposed tissue surfaces.

FIG. 13 illustrates a closure device of the present disclosure, which ispart of present disclosure's system for accessing a pericardial spaceand preventing strokes arising from the LAA.

FIG. 14 is a ninth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3.

FIG. 15 is a photo depicting an exemplary anatomy of an LAA.

FIG. 16 is an exemplary depiction of an LAA showing the presence ofdistinct protrusions within the LAA termed lobes.

FIG. 17 is an exemplary depiction of an LAA in accordance with thehour-glass concept.

FIG. 18 is another exemplary depiction of an LAA in accordance with thehour-glass concept which also displays the lobes, crypts and crevices ofthe LAA.

FIG. 19 is a tenth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 19illustrates the accentuation of the waist of the LAA ostium and the wallof the proximal portion of the LAA caused by the inflation of thenon-compliant balloon.

FIG. 20 is a perspective view depicting an optional step of theexemplary embodiment of FIG. 3.

FIG. 21 illustrates a perspective view of a tissue penetrating tipentering the LAA through a wall of the LAA.

FIG. 22 illustrates a perspective view of the tissue penetrating tip ofFIG. 21 extending into the LAA with a balloon inflated in the leftatrial cavity and is pulled back towards the LAA.

FIG. 23 illustrates a perspective view of at least one balloon inflatedwithin the LAA.

FIG. 24 illustrates a perspective view of an invagination of the LAA.

FIG. 25 illustrates a perspective view of a tissue penetrating tipentering the LAA through a wall of the LAA.

FIG. 26 illustrates a perspective view of a tissue penetrating tipentering the LAA through a wall of the LAA.

FIG. 27A illustrates a perspective view of a suction device contacting awall of a LAA.

FIG. 27B illustrates a perspective view of the suction device of FIG.27A.

FIG. 27C illustrates a front view of the end of the suction device ofFIG. 27A.

FIG. 28 illustrates a perspective view of an inflatable balloon inflatedwithin the LAA.

FIG. 29 illustrates a perspective view of an inflatable balloon inflatedwithin the LAA.

FIG. 30 illustrates a perspective view of an inflatable balloon inflatedwithin the LAA with a constricting tie placed thereon.

FIG. 31 illustrates a perspective view of a plurality of inflatableballoons inflated within the LAA with suction devices.

FIG. 32 illustrates a perspective view of a plurality of inflatableballoons inflated within the LAA with at least one suction device.

FIG. 33 illustrates a perspective view of a closure device positionedover the ostium of a LAA.

FIG. 34 illustrates a perspective view of a closure device positionedover the ostium of a LAA.

FIG. 35 illustrates a perspective view of a closure device positionedover the ostium of a LAA with a plurality of inflatable balloons havingbeen withdrawn from the LAA cavity.

FIG. 36 illustrates a perspective view of a plurality of inflatableballoons positioned within the LAA cavity and including magneticresponsive materials.

DETAILED DESCRIPTION OF THE DISCLOSURE

FIG. 1 is a perspective view of an exemplary embodiment of a catheter100, which is part of aspects of the present disclosure's system foraccessing a pericardial space and preventing strokes arising from theLAA. The present disclosure's system also includes closure device 1300,as shown in the exemplary embodiment of FIG. 13. FIG. 1 shows astand-alone catheter 100 before it is introduced into a body cavity andthus, FIG. 1 shows inflatable balloons 102, 104, 115 and 119 in theirun-inflated form. Inflatable balloon 104 is attached to an outer sheath103. Inflatable balloons 102 and 115 are attached to inner sheath 101.Inflatable balloon 119 is attached to inner catheter 117. Depending onthe desired degree of compliance, inflatable balloons 102, 104, 115 and119 can be made of rubber, latex, polyisoprene, silicone, polyurethane,or any combination thereof. Rubber, latex, polyisoprene, and siliconeproduce more compliant inflatable balloons. Polyurethane producesnon-compliant inflatable balloons. For non-compliant balloons, a higherpressure is ideal when inflating such balloons. A mixture of siliconeand polyurethane produces half-way compliant inflatable balloons.

A more compliant balloon will assume the contours of its surroundingswhen inflated. By contrast, a non-compliant balloon will expand thecontours of its surroundings when inflated. In this exemplary embodimentof FIG. 1, inflatable balloons 104 and 115 are more compliant and thus,when inflated, each assumes the contours of its surroundings, as shownin FIG. 4. Thus, inflated balloon 104 will assume the shape of thesmooth-walled left atrial cavity, whereas inflated balloon 115 willassume the shape of the rough-walled LAA. In particular, inflatedballoon 115 can cover the potential sites of tear and bleeding, such asthe lobes and recesses within the LAA walls.

By contrast, inflatable balloon 102 is non-compliant and thus, wheninflated, it expands the contours of its surrounding. As shown in FIG.4, an inflated balloon 102 expands the contours of the LAA wall. Byexpanding the contours of its surroundings, inflatable balloon 102accentuates the waist of the LAA ostium and the walls of the proximalportions of the LAA, as shown in FIG. 19. The ability of inflatableballoon 102 to accentuate the waist of the LAA ostium is an importantfeature because it prevents inflatable balloon 102 from falling into theleft atrial cavity, which is particularly important because a distinctconstriction is often absent at the LAA ostium. The application ofelectromagnetic or magnetic or suction forces will also result ininflated balloon 104 making a better contact with the smooth-wall leftatrium cavity wall. Moreover, the ability of inflatable balloon toaccentuate the LAA walls also helps cover the potential sites of tearand bleeding, such as the lobes and recesses within the LAA walls.

Optionally, inflatable balloons 102 and 115 can each have biocompatiblehydrogel coated to its exterior (not illustrated in FIG. 1).Biocompatible hydrogel expands upon contact with fluid, such as blood orwater. By absorbing the surrounding fluid, such as blood, the hydrogelhelps to inhibit bleeding from the left atrium to the pericardialcavity, or from the LAA into the pericardial cavity. Alternatively,inflatable balloons 102 and 115 can each have sponges attached to itsexterior (not illustrated in FIG. 1). The sponges will expand uponcontact with fluid, such as blood or water. Like the hydrogel, thepurpose of the sponges is to absorb surrounding fluid, such as blood,thereby inhibiting bleeding from the left atrium to the pericardialcavity, or from the LAA into the pericardial cavity.

Inflatable balloon 119 serves to anchor the LAA while (a) a closuredevice is being deployed to the LAA, and (b) the deflation of theinflated balloons if desired. Hence, inflatable balloon 119 can betermed the anchoring balloon.

Optionally, an additional inflatable balloon can be attached to thedistal end of outer sheath 103 (not shown in FIG. 1). This additionalinflatable balloon serves as an anchor and thus, is similar toinflatable balloon 119. This additional anchoring balloon prevents outersheath 103 from being pulled back, and thus, keeps inflatable balloon104 in-place. As shown in FIG. 20, this additional anchoring balloon canbe inflated adjacent to the fossa ovalis or the interatrial septum, asshown in FIG. 20.

Despite the foregoing, it is contemplated that inflatable balloons 102,104, 115 and 119 can each be compliant, semi-compliant, non-compliant,or any combination of the foregoing, depending on design needs.Additionally, it is contemplated that catheter 100 can be made up ofmore than four inflatable balloons depending on design needs.

Inflatable balloon 104 can be inflated with the input of air, or asuitable liquid material, such as saline, via inflation port 112 throughouter sheath openings 106 a, 106 b, and 106 c. Optionally, the suitableliquid material can be mixed with radiopaque contrast to provide spatialguidance. It is contemplated that the number of outer sheath openingscan vary depending on design needs. For example, inflatable balloon 104can be inflated via inflation port 112 through only one outer sheathopening, or through more than three outer sheath openings.

Inflatable balloons 102 and 115 can each be inflated with the input ofair, or a suitable liquid material, such as saline, via inflation port112 through inner sheath openings 105 a, 105 b, and 105 c, and 116 a,116 b, and 116 c, respectively. Optionally, the suitable liquid materialcan be mixed with radiopaque contrast to provide spatial guidance. It iscontemplated that the number of inner sheath openings can vary dependingon design needs. For example, inflatable balloons 102 and 115 can eachbe inflated via inflation port 112 through only one inner sheathopening, or through more than three inner sheath openings.

Inflatable balloon 119 can be inflated with the input of air, or asuitable liquid material, such as saline, via inflation port 112 throughinner catheter opening 120. Optionally, the suitable liquid material canbe mixed with radiopaque contrast to provide spatial guidance. It iscontemplated that the number of catheter openings can vary depending ondesign needs. For example, inflatable balloon 119 can be inflated viainflation port 112 through more than one inner catheter opening.

Inflation port 112 provides the portal for the input of air by, or asuitable liquid material, such as saline, by, for example, a ballooncatheter inflation device commonly known to one skilled in the art.Optionally, the suitable liquid material can be mixed with radiopaquecontrast to provide spatial guidance.

When inflated, inflatable balloon 104 has a larger diameter than that ofthe LAA ostium, as shown in FIG. 4. By having a larger diameter thanthat of the LAA ostium, inflatable balloon 104 is able to form aneffective hemostatic seal, and effectively occlude the LAA ostium.Optionally, inflatable balloon 104 can have caliber tubes attached toits exterior. These tubes will allow for the application of vacuum orsuction forces to the left atrial tissue or to the surface of theadjacent balloon to provide for a tighter hemostatic seal.

Optionally, catheter 100 can include electromagnetic coils.Electromagnetic coils can provide further support for firmly occludingthe LAA ostium. In this exemplary embodiment of FIG. 1, electromagneticcoils 114 are located within inflatable balloon 103, and electromagneticcoils 113 are located within inflatable balloon 102. When inflatableballoons 103 and 102 are inflated, electromagnetic coils 113 and 114also expand within the respective balloon, as shown in FIG. 4.Electromagnetic coils 113 and 114 are insulated wires coiled together toform a solenoid, and thus, can be made out of copper or any othermetallic wire capable of conducting electricity. In addition, catheter100 can also include magnetic elements where one element is a magnet andthe other element is a magnet or has a metallic component that isattracted to a magnet.

The distal end of inner catheter 117 has tissue-penetrating tip 118adapted to penetrate the LAA wall and the pericardial sac.Tissue-penetrating tip 118 can be a blunt or sharpened tip, and/or an RFelectrode delivering RF current, to puncture the LAA wall tissue andoptionally the pericardial sac tissue when optionally advanced out ofthe pericardial space as described below.

Optionally, the distal end of inner catheter 117 may include anelectromagnetic element. This electromagnetic element interacts with anelectromagnetic probe adapted to draw inner catheter 117 out of thepericardial cavity.

As duly noted by elongation identifier 121, the length of inner catheter117 can vary depending on the body cavity dimension of the particularpatient. As duly noted by elongation identifier 111, the length of innersheath 101 can vary depending on the body cavity dimensions of theparticular patient. Similarly, as duly noted by elongation identifier122, the length of outer sheath 103 can vary depending on the bodycavity dimensions of the particular patient.

Optionally, catheter 100 can include radiopaque marker bands. As shownin the exemplary embodiment of FIG. 1, radiopaque marker bands 107 a and107 b are thin metal tubes placed along inner sheath 101 to providespatial guidance under an X-ray fluoroscope.

Inner sheath 101 is introduced into the body cavity, and advanced untilradiopaque marker band 107 b reaches the mid-point of the LAA ostium, asshown in FIG. 2. When radiopaque marker band 107 b reaches the mid-pointof the LAA ostium, inflatable balloon 102 is inflated. Moreover,radiopaque marker band 107 b provides guidance for advancing outersheath 103. In particular, outer sheath 103 is introduced into the bodycavity and advanced through the body cavity until outer sheath 103reaches radiopaque marker band 107 b.

After balloons 102, 104, and 115 are inflated, locking means 109 isactivated. Locking means 109 is shown in FIG. 2. Locking means 109 is aspring-loaded device housed in inner sheath 101 that, upon activation,the protrusions would bulge out through the corresponding protrusionslots on outer sheath 103, as shown in FIG. 2. These protrusions andcorresponding protrusion slots can be of varying dimensions. The purposeof locking means 109 is to render stationary inflated balloons 102 and104 so that the hemostatic seal is firmly occluding the LAA ostium.

Optionally, an additional locking mechanism similar to locking means 109can be present on outer sheath 103 (not illustrated in FIG. 1). Thisadditional locking mechanism would be used to render stationary (a) anadditional anchoring balloon inflated within the left atrium adjacent tothe interatrial septum, and (b) outer sheath 103. Like locking mechanism109, this additional locking mechanism would be a spring-loaded devicehoused in inner sheath 101 that, upon activation, the protrusions wouldbulge out through the corresponding protrusion slots on outer sheath103, as shown in FIG. 2. These protrusions and corresponding protrusionslots can be of varying dimensions.

Control port 110 provides the portal for connection to catheter handlingdevices designed to control and navigate inner sheath 101, outer sheath103, and inner catheter 117 to the desired locations. Inner sheath 101,outer sheath 103, and inner catheter 117 can also be steerable such thateach are deflectable with pull wire technology or other methods to allowfor the respective tips to be deformed in the desired direction.

FIG. 2 is a perspective view of the locking means in the exemplaryembodiment of FIG. 1. Locking means 109 is a spring-loaded device housedin inner sheath 101 that, upon activation, the protrusions would bulgeout through the corresponding protrusion slots on outer sheath 103.These protrusions and corresponding protrusion slots can be of varyingdimensions. The purpose of locking means 109 is to render stationaryinflated balloons 102 and 104 so that the hemostatic seal is firmlyoccluding the LAA ostium.

FIG. 3 is a flowchart depicting an exemplary embodiment of the presentdisclosure's method for accessing a pericardial space and preventingstrokes arising from the LAA. At step 301, catheter 100 is introducedinto a body cavity. Typically, catheter 100 can be introduced in thebody cavity via a puncture. Catheter 100 can be introduced intodifferent body cavities, such as via a femoral vein, a jugular vein, anaxillary vein, or a subclavian vein. Alternatively, catheter 100 canalso be introduced directly into the chambers of the heart viaintroduction at the right atrium and advanced to the left atrium, asshown in FIGS. 5-7. In yet another embodiment, catheter 100 can beintroduced directly into the chambers of the heart via introduction atthe apex of the left ventricle. As shown in FIG. 1, catheter 100comprises inner sheath 101, outer sheath 103, and inner catheter 117,among other components.

At step 302, inner sheath 101 is advanced to position a distal end ofinner sheath 101 within an interior of the LAA. As shown in FIGS. 4-5,inner sheath 101 can be advanced to position its distal end within theLAA interior via a left atrium. Inner sheath 101 (as well as outersheath 103 at step 306 and inner catheter at step 310) may be advancedto the left atrium by any known technique, including transseptaldelivery where the left atrium is accessed from the right atrium,thorascopic delivery, via a retrograde transaortic approach, and thelike. Optionally, catheter 100 may comprise radiopaque marker bands,such as radiopaque marker band 107 a and 107 b, which can providespatial guidance for positioning the distal end of inner sheath 101within the LAA interior.

At step 303, inflatable balloon 102 is inflated within an interior ofthe LAA adjacent to the LAA ostium, as shown in FIG. 4. Inflatableballoon 102 can be inflated with the input of air, or a suitable liquidmaterial, such as saline, via inflation port 112 through inner sheathopenings 105 a, 105 b, and 105 c. Optionally, the suitable liquidmaterial can be mixed with radiopaque contrast to provide spatialguidance. Inflatable balloon 102 is inflated with high occlusivepressures because it is a non-compliant balloon. Because inflatableballoon 102 is non-compliant, it expands the contours of its surroundingwhen inflated. The LAA is distensible and hence should readily deform inresponse to high pressure inflation with non-compliant balloon 102.Thus, as shown in FIG. 19, non-compliant balloon 102 accentuates thewaist of the LAA interior adjacent to the LAA ostium to prevent aninflated non-compliant balloon 102 from falling into the left atrium,which is particularly important because a distinct constriction is oftenabsent at the LAA ostium. Additionally, due to the presence of deepcrypts or recesses in-between the pectinate muscles and the presence ofprotrusions or lobes in the LAA interior, as shown in FIGS. 16, 18-19,an inflated non-compliant balloon 102 also accentuates these crypts,recesses, protrusions, and lobes. Therefore by expanding the contours ofits surroundings in the LAA interior, non-compliant balloon creates amore effective hemostatic seal circumferentially about the LAA ostium.This hemostatic seal inhibits bleeding from the left atrium into thepericardial cavity. Optionally, the presence of this hemostatic seal canbe confirmed (step not illustrated) with a test injection of contrastfrom the tip of inner sheath 101 to ensure that the contrast injectedinto the LAA does not flow back into the left atrium.

Optionally, another embodiment of this method may include a set ofelectromagnetic coils 113 located within inflatable balloon 102, and aset of electromagnetic coils 114 located within inflatable balloon 104.Thus, when balloons 102 and 104 are inflated, electromagnetic coils 113and 114 also expand within the respective balloon, respectively. By wayof electromagnetic forces created by these electromagnetic coils,inflated balloon 102 is pulled towards the LAA ostium by electromagneticcoils 114. Conversely, inflated balloon 104 is pulled towards the LAAostium by electromagnetic coils 113. Thus, these electromagnetic forcespromote attraction between inflated balloons 102 and 104, therebyfurther enhancing the hemostatic seal circumferentially about the LAAostium. Similarly, instead of electromagnetic coils, the catheter canalso include magnetic elements where one element is a magnet and theother element is a magnet or has a metallic component that is attractedto a magnet.

At step 304, inflated balloon 102 is pulled in a direction from withinthe LAA interior and towards to the LAA ostium to occlude the LAAostium. Inflated balloon 102 can be pulled in a direction from withinthe LAA interior and towards to the LAA ostium by pulling on innersheath 102 in the same direction.

At step 305, inflatable balloon 115 is inflated within a distal portionof the LAA interior, as shown in FIGS. 4 and 19. Inflatable balloon 115can be inflated with the input of air, or a suitable liquid material,such as saline, via inflation port 112 through inner sheath openings 116a, 116 b, and 116 c. Optionally, the suitable liquid material can bemixed with radiopaque contrast to provide spatial guidance. Inflatableballoon 115 is more compliant and thus, when inflated, it assumes thecontours of its surroundings, as shown in FIGS. 4 and 19. By assumingthe contours of its surroundings in the LAA, inflated balloon 115 sealsthe potential sites for tear or perforation in the LAA wall, therebyinhibiting bleeding (a) from the left atrium into the pericardialcavity, and (b) from the LAA into the pericardial cavity. Additionally,due to the presence of deep crypts or recesses in-between the pectinatemuscles and the presence of protrusions or lobes in the LAA interior, asshown in FIGS. 16, 18-19, an inflated balloon 115 also covers thesecrypts, recesses, protrusions, and lobes. Furthermore, inflated balloon115 pushes inflated balloon 102 towards the LAA ostium.

Optionally, inflatable balloons 102 and 115 can each have biocompatiblehydrogel coated to its exterior (step not illustrated in FIG. 3).Biocompatible hydrogel expands upon contact with fluid, such as blood orwater. By absorbing the surrounding fluid, such as blood, the hydrogelhelps to inhibit bleeding from the left atrium to the pericardialcavity, or from the LAA into the pericardial cavity. Alternatively,inflatable balloons 102 and 115 can each have sponges attached to itsexterior (step not illustrated in FIG. 3). The sponges will expand uponcontact with fluid, such as blood or water. Like the hydrogel, thepurpose of the sponges is to absorb surrounding fluid, such as blood,thereby inhibiting bleeding from the left atrium to the pericardialcavity, or from the LAA into the pericardial cavity.

At step 306, outer sheath 103 is advanced to position a distal end ofouter sheath 103 in a portion of the left atrium adjacent to the LAAostium, as shown in FIGS. 4 and 19.

At step 307, inflatable balloon 104 is inflated within a portion of theleft atrium adjacent to the LAA ostium, as shown in FIGS. 4 and 19.Inflatable balloon 104 can be inflated with the input of air, or asuitable liquid material, such as saline, via inflation port 112 throughouter sheath openings 106 a, 106 b, and 106 c. Optionally, the suitableliquid material can also be mixed with radiopaque contrast. Unlike theLAA interior, the left atrium portion adjacent to the LAA ostium issmooth-walled. When inflated, balloon 104 has a larger diameter thanthat of the LAA ostium, as shown in FIG. 4. By having a larger diameterthan that of the LAA ostium, inflated balloon 104 envelops the LAAostium to firmly occlude the LAA ostium to create an effectivehemostatic seal, thereby inhibiting bleeding from the left atrium intothe pericardial cavity. Additionally, inflated balloon 104 preventsinflated balloon 102 from falling into the left atrium and thus,inflated balloon 104 helps render stationary inflated balloon 102 withinthe LAA interior.

At step 308, inflated balloon 104 is pushed in a direction from withinthe left atrium portion adjacent to the LAA ostium and towards the LAAostium. Inflated balloon 104 can be pushed in a direction from withinthe left atrium portion adjacent to the LAA ostium and towards the LAAostium by pushing the outer sheath in the same direction. As a result,inflated balloon 104 occludes the LAA ostium more firmly to create aneffective hemostatic seal, thereby inhibiting bleeding from the leftatrium into the pericardial cavity. Additionally, inflated balloon 104prevents inflated balloon 102 from falling into the left atrium andthus, inflated balloon 104 helps render stationary inflated balloon 102within the LAA interior.

Optionally, inflated balloon 104 has caliber tubes attached to itsexterior (step not shown in FIG. 3). These tubes will allow for theapplication of vacuum or suction forces to the left atrial tissue or tothe surfaces of the adjacent balloon to provide for a tighter hemostaticseal.

At step 309, locking means 109 is activated. Locking means 109 is aspring-loaded device housed in inner sheath 101 that, upon activation,the protrusions would bulge out through the corresponding protrusionslots on outer sheath 103. These protrusions and correspondingprotrusion slots can be of varying dimensions. The purpose of lockingmeans 109 is to render stationary inflated balloons 102 and 104 so thatthe hemostatic seal is firmly occluding the LAA ostium.

Optionally, another embodiment of this method may include anadditionally step of inflating an additional inflatable balloon locatedon the outer sheath, as shown in FIG. 20. This additional inflatableballoon is inflated in a portion of the left atrium adjacent to thefossa ovalis or the interatrial septum, as shown in FIG. 20. Thisballoon serves as an anchor to render stationary inflated balloon 104.Optionally, an additional locking mechanism similar to locking means 109can be present on outer sheath 103 (not illustrated in FIG. 1). Thisadditional locking mechanism would be used to render stationary (a) anadditional anchoring balloon inflated within the left atrium adjacent tothe interatrial septum, and (b) outer sheath 103. Like locking mechanism109, this additional locking mechanism would be a spring-loaded devicehoused in inner sheath 101 that, upon activation, the protrusions wouldbulge out through the corresponding protrusion slots on outer sheath103, as shown in FIG. 2. These protrusions and corresponding protrusionslots can be of varying dimensions.

At step 310, inner catheter 117 is advanced to position a distal end ofinner catheter 117 within a distal portion of the LAA interior near anapex of the LAA. As shown in FIG. 1, the distal end of inner catheter117 comprises tissue-penetrating tip 118.

At step 311, tissue-penetrating tip 118 of inner catheter 117 puncturesa wall of the LAA apex from within the LAA interior and into thepericardial cavity, as shown in FIG. 6. Tissue-penetrating tip 118 canbe a blunt or sharpened tip, and can further comprise a RF electrodedelivering RF current sufficient to puncture the LAA wall tissue and theparietal pericardium. Upon puncturing the wall of the LAA apex, nosignificant blood will enter the pericardial cavity because of the tighthemostatic seal previously formed by the inflated balloons. Aftertissue-penetrating tip 118 punctures the LAA wall, the distal end ofinner catheter 117 is advanced into the pericardial cavity, as shown inFIG. 6.

At step 312, the distal end of inner catheter 117 advances through thepericardial cavity, along the anterior surface of the ventricle, to aregion adjacent to the sternum, and in particular, the xiphisternum, asshown in FIGS. 7-8A. The xiphisternum, also known as the xiphoidprocess, is the lowermost part of the sternum. Alternatively, innercatheter 117 can be advanced through the pericardial cavity to anothersite at which inner catheter 117 will be exteriorized. Other desiredsites of exteriorization include the parietal pericardium in the rightor left pectoral regions, as such as FIG. 8B. This will allow forinsertion of the snare to ligate the LAA with an incision made in theskin over the intercostal space in the right or left pectoral regions(the desired site of exteriorization). Furthermore, other desired sitesof exteriorization may include any other region higher up in the chest,lateral to the sternum between the ribs.

At step 313, when inner catheter 117 reaches the desired site ofexteriorization, tissue-penetrating tip 118 punctures the wall of thepericardial cavity at this site. This wall of the pericardial cavity isalso known as the parietal pericardium. The pericardial cavity ispunctured from within the pericardial cavity in an outward direction atthe desired site of exteriorization, and inner catheter 117 enters thesubcutaneous tissues at the desired site of exteriorization. As shown inFIGS. 7-8A, a desired site of exteriorization is the region adjacent tothe xiphisternum. Alternatively, as shown in FIG. 8B, other desiredsites of exteriorization include the parietal pericardium in the rightor left pectoral regions.

At step 314, inner catheter 117 is externalized or “pulled out” from thepericardial cavity with manual force, electromagnetic force, radiofrequency energy delivery, or any combination thereof. For example, asshown in FIG. 8A, inner catheter 117 can be externalized from thepericardial cavity with electromagnetic forces applied with anothercatheter having an electromagnetic probe that is placed at the desiredsite of exteriorization. A small incision can be made in the skin to theleft of the xiphisternum, or higher up in the chest for example, lateralto the sternum between the ribs. An electromagnetic probe is introducedtowards the pericardial cavity through this incision to attract innercatheter 117 (that has electromagnets incorporated) that is thenexteriorized. The distal end of inner catheter 117 may include anelectromagnetic element, which interacts with the electromagnetic probeadapted to draw inner catheter 117 out of the pericardial cavity.Application of RF current may also be considered to draw inner catheter117 out of the pericardial cavity.

At step 315, inner catheter 117 is advanced to position a proximal endof inner catheter 117 within the distal portion of the LAA interior nearthe LAA apex, as shown in FIG. 14.

At step 316, inflatable balloon 119 is inflated within the distalportion of the LAA interior near the LAA apex, as shown in FIG. 14.Inflatable balloon 119 can be inflated with the input of air, or asuitable liquid material, such as saline, via inflation port 112 throughinner catheter opening 120. Optionally, the suitable liquid material canbe mixed with radiopaque contrast to provide spatial guidance.Inflatable balloon 119 serves to anchor the LAA and hence, inflatedballoon 119 can be termed the anchoring balloon.

At step 317, inflated balloon 119 is pulled in a direction from withinthe distal portion of the LAA interior near the LAA apex and towards thepericardial cavity to anchor the LAA. Inflated balloon 119 can be pulledin a direction from within the distal portion of the LAA interior nearthe LAA apex and towards the pericardial cavity by pulling innercatheter 117 in the same direction. This will serve to straighten theLAA (a structure than can be very tortuous in its course) and thus makeit easier to (a) advance closure device 1300 over the exterior of theLAA, and (b) deflate the inflated balloons (step not illustrated).

At step 318, the exteriorized inner catheter 117 is used as a rail overin which closure device 1300 is advanced to the LAA, and is advancedover the exterior of the LAA to a position overlying the LAA ostium sothat closure will seal the interior of the LAA and isolate any clot fromthe left atrium, as shown in FIG. 9. Closure device 1300 is made up ofsuture 1301 looped through two semi-rigid hollow tubes 1302 and 1303which can function as a “lasso” or a “snare,” as shown in FIGS. 9 and11-13.

At step 319, closure device 1300 is deployed over the exterior of theLAA ostium, as shown in FIGS. 9 and 11-13. Closure device 1300 isdeployed over the exterior of the LAA ostium by position each of thesemi-rigid hollow tubes along the short axis (or short diameter) of theexterior of the LAA ostium, and thereafter tightening the suture to sealthe interior of the LAA ostium. As shown in FIG. 11, closure device 1300applies forces along the short axis or short diameter of the oval orelliptical LAA ostium, thereby sealing the LAA ostium without apuckering effect. Optionally, as shown in FIG. 13, semi-rigid tubes 1302and 1303 may be coated over at least an inner surface with a hydrogel,silicone gel, and/or other biocompatible material. Hydrogels will expandon contact with water or blood to further compress the LAA ostium.

At step 320, the endocardial surface of the interior of the LAA ostiumis thermally or mechanically injured to induce a tissue response thatenhances closure and sealing, as shown in FIG. 12. For example, thermalinjury may be induced by circulating a hot fluid through inflatedballoons 102 and 104 that are occluding the LAA ostium. Such injury maycomprise delivering heat through inflated balloons 102 and 104 viacirculation of externally heated liquids such as dextrose, glycine,saline, and glycerine, and thus creating conductive heating.Alternatively, the LAA tissue may be injured or fused by applying RFcurrent through inflated balloons 102 and 104, and/or the externalclosure device. The RF current is delivered through inflated balloons102 and 104 and/or closure device 1300, and creating resistive heatingof the ostial tissues. Apposition of injured surfaces will cause “tissuewelding,” i.e. cross linking of the tissue collagen, resulting in a morecomplete closure. Other energy sources, such as high energy focusedultrasound, mechanical abrasion, laser or cryoablation, may also beused. The combination of pressure exerted by a clip or barrette andadhesions formed at the endocardial surface will exert a synergisticeffect in ensuring that the occlusion at the LAA ostium is complete andpersistent.

Optionally, after step 20 (steps not illustrated in FIG. 3), analternative embodiment can further include the steps of: deflating thefirst inflated balloon, deflating the second inflated balloon, deflatingthe third inflated balloon, deactivating the locking mechanism, removingthe outer sheath from the body cavity, and removing the inner sheathfrom the body cavity.

FIG. 4 is a first perspective view depicting the initial steps of theexemplary embodiment of FIG. 3.

FIG. 5 is a second perspective view depicting the initial steps of theexemplary embodiment of FIG. 3.

FIG. 6 is a third perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 6illustrates the advancement of the inner catheter through the wall ofthe LAA and into the pericardial cavity surrounding the heart.

FIG. 7 is a fourth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 7illustrates the further advancement of the inner catheter through thepericardial cavity and into a region adjacent to the xiphisternum.

FIG. 8A is a fifth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 8Aillustrates the inner catheter being “pulled out” and exteriorized byway of electromagnetic forces.

FIG. 8B illustrates alternative sites for exteriorizing the innercatheter after it has been drawn from the pericardial site.

FIG. 9 is a sixth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 9 shows thedeployment of the closure device being advanced over the exteriorizedinner catheter and to the LAA ostium.

FIG. 10 illustrates a prior art closure device employing a loop orsuture which results in puckering of the LAA ostium. With a ligatingcircumferentially applied suture, such as in a “purse string” manner,the fixed circumference of the LAA is now compressed by the suture intoa smaller area. Hence, a puckering of the LAA ostium results. Withpuckering, communications are likely to occur between the left atriumand the LAA. The ostium of the LAA is likely to be incompletelyoccluded. This is especially true of the ostium of the LAA which is morean oval rather than a circular structure. The circumference or perimeterthat remains fixed is being compressed into a smaller area by theconstricting suture or tie. Furthermore, a circumferentially tied-sutureis also more likely to cause a tear in the LAA wall. Therefore,puckering compromises the occlusion of the LAA and potentially allowsthe release of clot back into the left atrium.

FIG. 11 is a seventh perspective view depicting the intermediate stepsof the exemplary embodiment of FIG. 3, and in particular, FIG. 9illustrates the deployment of the closure device being deployed over theexterior of the LAA ostium without creating a puckering of the LAAostium. With the application of a flat clip or similar closure, thecircumference of the base of the LAA is not compressed into a smallerarea and puckering does not result. Closure device 1300 is an example ofa clip-like device. During deployment of closure device 1300, forces areapplied along the short axis/diameter of the oval LAA ostium. Closuredevice 1300 applies forces along the short axis or short diameter of theoval or elliptical LAA ostium. Hence, a barrette or clip-like devicesuch as closure device 1300 applied at the ostium of the LAA is morelikely to seal off the structure. Force applied along the long diameteris less likely to approximate the opposite surfaces since (a) the twosurfaces will have to travel a longer distance and (b) a greater amountof force will be necessary to overcome the elasticity/recoil of thetissue. Such a clip, such as closure device 1300, is also less likely totear or lacerate the LAA than a suture.

FIG. 12 is an eighth perspective view depicting the intermediate stepsof the exemplary embodiment of FIG. 3, and in particular, FIG. 12illustrates the injury of the inner surface of the LAA prior to closure,where the injury causes an injury response which results in a morecomplete sealing along the opposed tissue surfaces.

As shown in FIG. 12, the inner wall of the LAA ostium will preferably beinjured to induce to induce a tissue response that enhances closure andsealing. For example, thermal injury may be induced by circulating a hotfluid through inflated balloons 102 and 104 that are occluding the LAA.Alternatively, the LAA tissue may be injured or fused by applying RFcurrent through inflated balloons 102 and 104, and/or the externalclosure device. Apposition of injured surfaces will cause “tissuewelding,” such as cross linking of the tissue collagen, resulting in amore complete closure. Other energy sources, such as high energy focusedultrasound, mechanical abrasion, laser or cryoablation, may also beused. The combination of pressure exerted by a clip or barrette andadhesions formed at the endocardial surface will exert a synergisticeffect in ensuring that the occlusion at the LAA ostium is complete andpersistent.

FIG. 13 illustrates a closure device of the present disclosure, which ispart of the present disclosure's system for accessing a pericardialspace and preventing strokes arising from the LAA. Closure device 1300comprises suture 1301, and hollow tubes 1302 and 1303. Hollow tubes 1302and 1303 are preferably semi-rigid tubes that are designed to functionas a clip or a barrette when closed over the base of the LAA. The use ofthe flat clip or barrette structure is a significant advantage overusing a suture loop or equivalent closure. As shown in FIG. 10, acircumferential suture applied in a “purse string” manner), compressesthe base of the LAA into a smaller area causing puckering of the ostium.Such puckering compromises the occlusion and potentially allows therelease of a clot back into the left atrium. With the application of aflat clip or similar closure, the circumference of the LAA ostium is notcompressed into a smaller area and puckering does not result. Duringapplication of the clip-like device, forces are applied along the shortaxis/diameter of the oval LAA ostium.

An exemplary clip that approximates opposed surfaces of the LAA ostiumis illustrated in FIG. 11. The clip applies forces along the short axisor short diameter of the oval or elliptical LAA ostium. Hence, abarrette or clip applied at the ostium of the LAA is more likely to sealoff the structure. Force applied along the long diameter is less likelyto approximate the opposite surfaces since (a) the two surfaces willhave to travel a longer distance and (b) a greater amount of force willbe necessary to overcome the elasticity/recoil of the tissue. Such aclip is also less likely to tear or lacerate the LAA than a suture.

Optionally, hollow tubes 1302 and 1303 may be coated over at least aninner surface with a hydrogel, silicone gel, and/or other biocompatiblematerial. Hydrogels will expand on contact with water or blood tofurther compress the ostium of the LAA. It is possible that thethickness of the coating may vary and may be greater over themid-portion of the tubes. The ability of the clip-like closures of thepresent disclosure to slide and adjust position over the LAA contributesto the stability and tight closure which is achieved.

FIG. 14 is a ninth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3. FIG. 14 illustrates an anchoringmechanism to provide tension or traction to (a) facilitate the placementof closure device 1300 over the exterior of the LAA ostium, and (b)facilitate the deflation and removal of inflated balloons 102, 104, and115, inner sheath 101 and outer sheath 103.

FIG. 15 is a photo depicting an exemplary anatomy of an LAA. LA is theleft atrium. LSPV is the left superior pulmonary vein. L is the lengthof the LAA. W is the width of the LAA. O_(a) is the diameter of the LAAostium with respect to the rough-walled portions of the LAA. Forexample, upon inflation, balloon 102 is approximated against O_(a).O_(e) is the diameter of the LAA ostium with respect to thesmooth-walled portions of the left atrial cavity. For example, uponinflation, balloon 103 is approximated against O_(e). The upright arrowat the bottom shows an in-folding or constriction at the LAA ostium.However, this constriction is absent or less prominent at the oppositesurface. In many specimens, a distinct circumferential constriction isabsent at the ostium of the LAA. This raises the possibility that uponinflation of a balloon within the LAA, it may fall out of the LAA intothe left atrial cavity. Inflated balloon 104 prevents inflated balloon102 from falling into the left atrial cavity. Hence, the presentdisclosure provides for a plurality of inflatable balloons to create amore effective hemostatic seal.

Additionally, as shown in FIG. 15, nearly all LAA of an average adultcontains pectinate muscles of greater than 1-mm in diameter. This givesthe LAA a rough quality unlike the left atrial cavity, which issmooth-walled. Additionally, as shown in FIG. 15, deep recesses arepresents within the LAA in-between the pectinate muscles. The presenceof these recesses in-between the pectinate muscles make it difficult fora singular inflated balloon to effectively seal the LAA. Hence, thepresent disclosure provides for a plurality of inflatable balloons tocreate a more effective hemostatic seal.

FIG. 16 is an exemplary depiction of an LAA showing the presence ofdistinct protrusions termed lobes within the LAA. 1601 is thecircumference of the LAA ostium. 1602, 1603, and 1604 are protrusionstermed lobes and are located within the LAA. The presence of lobes 1602,1603, and 1604 and the recesses in-between the pectinate muscles make itdifficult for a singular inflated balloon to effectively seal the LAA.Hence, the present disclosure provides for a plurality of inflatableballoons to create a more effective hemostatic seal.

FIG. 17 is an exemplary depiction of an LAA in accordance with thehour-glass concept. One of the key factors affecting the time measuredin the hour-glass is the neck width. The present disclosure is based onthe concept that preventing the sand or water flowing from the top bulbto the bottom is achieved by occluding or sandwiching the neck by acombination of balloons rather by inflating one balloon in the bottombulb only. The balloons (inflatable balloons 102 and 104) that areplaced immediately across the neck are approximated towards each otherby a combination of pushing and pulling. For example, inflatable balloon102 is pushed upwards by inflatable balloon 115 and is pulled by manualtraction on inner sheath 101 as well as by electromagnetic coils 114applied from inflatable balloon 104. Inflatable balloon 104 is pushedtowards the neck and towards inflatable balloon 102 by manual forcesapplied on outer sheath 103 and are also pulled by electromagneticforces 113 (or suction forces) applied from inflatable balloon 102. Thetop bulb represents the left atrial cavity while the bottom bulbrepresents the LAA. The neck represents the LAA ostium.

FIG. 18 is another exemplary depiction of an LAA in accordance with thehour-glass concept. The detailed description of FIG. 17 is equallyapplicable to FIG. 18. The top bulb represents the smooth-walled leftatrial cavity while the bottom bulb of the hour glass represents therough-walled LAA with the pectinate muscles and lobes. Upon inflation,inflatable balloons 102 and 115 are less likely to provide an effectivehemostatic seal without inflatable balloon 104. Inflatable balloon 104is approximated against the smooth-walled left atrial cavity. Inflatableballoon 104 serves as the key expanding element because (a) it preventsinflatable balloon 102 from falling into the left atrium, and (b) firmlyoccludes the LAA ostium to enhance the hemostatic seal. By way ofelectromagnetic coils 113, inflatable balloon 104 is pulled towards theneck of the hour-glass, which is the LAA ostium. Inflatable balloon 115pushes inflatable balloon 102 towards the LAA ostium.

FIG. 19 is a tenth perspective view depicting the intermediate steps ofthe exemplary embodiment of FIG. 3, and in particular, FIG. 19illustrates the accentuation of the waist of the LAA ostium and the wallof the proximal portion of the LAA caused by the inflation of thenon-compliant balloon. For brevity, the detailed descriptions of steps302 to 308 of FIG. 3 are incorporated by reference herein. Inflatableballoon 102 is inflated within the LAA interior adjacent to the LAAostium. Inflatable balloon 102 is non-compliant and is inflated withhigher pressure. As a non-compliant balloon, inflatable balloon 102deforms and expands the walls of the LAA and in particular, the waist ofthe LAA. As shown in FIG. 19, the dotted line shows the expansion ofthese LAA walls and LAA waist by inflated balloon 102. The dotted lineshows the expansion of these LAA walls and LAA waist. The LAA is moredistensible than the left atrium and hence, should readily deform inresponse to a high pressure inflation of non-compliant balloon 102.After inflation, non-compliant balloon 102 is pulled towards the LAAostium. Inflatable balloon 115 is inflated within the distal portion ofthe LAA interior and is largely compliant. Upon inflation, balloon 115conforms to its surroundings in the LAA and pushes inflated balloon 102towards the LAA ostium, as shown in FIG. 19. Additionally, inflatedballoon 115 prevents inflated balloon 102 from being pushed away fromthe LAA ostium. Inflatable balloon 104 is inflated within the leftatrium portion adjacent to the LAA ostium, as shown in FIG. 19. Afterinflation, balloon 104 is pushed towards the LAA ostium, and willprevent inflated balloon 102 from falling into the left atrium. Finally,inflated balloons 102 and 104 are manually pushed towards each other bypulling on the inner sheath and pushing on the outer sheath,respectively.

Alternatively, it is contemplated that one inflatable balloon can havemultiple internal compartments within the balloon such that eachinternal compartment effectively operates as a separate inflatableballoon. For example, it is contemplated that one inflatable balloon canhave three internal compartments such that each of these three internalcompartments effectively operate in a similar manner as inflatableballoons 102, 104, and 115 shown in FIG. 19, respectively. Thus, uponinflation, this one inflatable balloon covers the area from (a) theregion of the left atrium adjacent to the LAA ostium, to (b) the distalportions of the LAA interior, as currently achieved by the combinationof inflatable balloons 102, 104, and 115 shown in FIG. 19.

FIG. 20 is a perspective view depicting an optional step of theexemplary embodiment of FIG. 3. Optionally, another embodiment of thismethod may include an additionally step between steps 309 and 310 ofinflating an additional inflatable balloon 123 located on outer sheath103, as shown in FIG. 20. Inflatable balloon 123 is attached to thedistal end of outer sheath 103, and is inflated within a portion of theleft atrium adjacent to the interatrial septum, as shown in FIG. 20.Alternatively, inflatable balloon 123 can be inflated adjacent to thefossa ovalis. This balloon serves as an anchor to render stationaryinflated balloon 104 and prevent outer sheath 103 from getting pulledback.

FIG. 21 illustrates an aspect of the present disclosure in which atissue-penetrating tip 2102 may enter the LAA through a wall of the LAA,as disclosed in U.S. patent application Ser. No. 13/922,070, entitled“APPARATUS AND METHOD FOR TREATING BLEEDING ARISING FROM LEFT ATRIALAPPENDAGE,” filed Jun. 19, 2013. The entire contents of U.S. patentapplication Ser. No. 14/941,457 are incorporated herein by reference,including the portion of U.S. patent application Ser. No. 14/941,457directed to entering the wall of the LAA through a wall of the LAA. Inthis situation, the LAA is being entered from the exterior/pericardialspace that has been accessed surgically.

The tissue-penetrating tip 2102 may enter the LAA at or near the apex ortip of the LAA.

FIG. 22 illustrates an aspect of the present disclosure in which thetissue-penetrating tip 2102 has proceeded into the Left Atrium Cavity.The tissue-penetrating tip 2102 may be the tip of a body 2202 thatextends through the LAA. Inflatable balloons 2204, 2206 may be coupledto sheaths 2208 (of different diameters that can slide over each otherand thus the balloons can be moved with respect to each other) thatextends over the body 2202. The balloons 2204, 2206 may be inflated inany manner disclosed in U.S. patent application Ser. No. 14/941,457 orthe present application to produce a seal of the LAA ostium. In oneembodiment, electromagnetic coils 2210, 2212 may be used to attract theballoons 2204, 2206 towards each other in any manner disclosed in U.S.patent application Ser. No. 14/941,457 or the present application. FIG.23 illustrates the balloons 2204, 2206 attracted towards each other toproduce a seal of the LAA ostium using magnetic, electromagnetic orsuction forces.

FIG. 24 is a representation of a possible complication with inserting atissue-penetrating tip 2402 through a wall 2404 of a LAA 2406. It ispossible that the wall 2404 may invaginate upon puncture by the tip2402, as represented by the dashed lines in FIG. 24. This may beundesirable, as the tip 2402 may puncture the wall 2404 abruptly,resulting in a tear of the LAA and bleeding. The wall 2404 of the LAA2406 is thin, compliant, and collapsible, which may increase thepossibility of invagination.

FIG. 25 illustrates an embodiment of the present disclosure, in which asuction device is utilized. The suction device may comprise a device forapplying a suction force to a surface 2504 of the LAA 2406. The surface2504 may comprise an outer surface of a wall of the LAA 2406. In oneembodiment, the suction device may comprise a tube 2502, as shown inFIG. 25, including a lumen 2506 for transmitting the suction forcethrough low pressure, or vacuum, or the like. In other embodiments,another form of suction device may be utilized. An end 2508 of the tube2502 may be configured to be placed against the outer surface of the LAA2406 to apply the suction force.

The suction force applied by the suction device may serve to stabilizethe LAA 2406 while the LAA 2406 is being punctured by the tip 2402. Thesuction force may hold the wall of the LAA 2406, and may also draw thewall of the LAA 2506 towards the end 2508 of the suction device, toreduce the possibility of invagination. The suction force may hold thewall of the LAA 2406 while the tip 2402 punctures the wall from exteriorof the LAA 2506 to interior of the LAA 2506. The tip 2402 may comprise atip of a body 2510 that extends within the tube 2502. The body 2510 maypass through the lumen 2506 of the tube 2502. The body 2510 may extendcoaxial with the suction device.

FIG. 26 illustrates an embodiment of the present disclosure in which thesuction device includes a sheath 2602 that extends over the tube 2502.The suction device may comprise the sheath 2602, which provides asuction force, and may also incorporate suction provided by the tube2502. The sheath 2602 may extend over the outer surface of the tube2502. The sheath 2602 may have a greater diameter than the tube 2502,and accordingly the tube 2502 may extend within the lumen of the sheath2602 and will be advanced forwards towards the LAA as the tip is pulledback by suction forces applied by the tube. The sheath 2602 may includean end 2510 that is configured to be placed against the outer surface ofthe LAA 2406 to apply the suction force. The additional diameter of thesheath 2602 by enveloping the puncture may provide for additionalcontrol of the LAA during puncture by the tip 2402.

FIGS. 27A-C illustrate an embodiment of a suction device 2702 includinga plurality of tubes 2704 a-c. FIG. 27A illustrates a side perspectiveview of the suction device 2702 applying a suction force to a surface2504 of the LAA. The plurality of tubes 2704 a-c may be coupled to acentral tube 2706. The central tube 2706 may include a lumen 2708 forthe tissue penetrating tip 2102 to pass therethrough, in a similarmanner as with the tube 2502.

The plurality of tubes 2704 a-c may be spaced apart from each other onthe central tube 2706. In one embodiment, the plurality of tubes 2704a-c may be positioned on an outer surface of the tube 2706. In oneembodiment, the plurality of tubes 2704 a-c may have a varied positionor orientation than show in FIGS. 27A-C. In one embodiment, a variednumber of tubes 2704 a-c than shown in FIGS. 27A-C may be utilized.

The plurality of tubes 2704 a-c may each be configured to apply asuction force to the surface of a LAA. The multiple tubes 2704 a-cutilized may disperse the position of the suction force, to reduce thepossibility of a single suction force being applied to the surface ofthe LAA at a single location. The multiple tubes 2704 a-c may also havea diameter that is smaller than the central tube 2706. The smaller sizeof the multiple tubes 2704 a-c may also reduce the possibility of aportion of the wall of the LAA being sucked into one of the tubes 2704a-c or the lumen of the central tube 2706. If a portion of the wall ofthe LAA is sucked into any of the tubes disclosed herein, then an unevenor undesired puncture of the LAA wall may occur, as the LAA wall mayenter the tube unevenly. Different points of suction may be provided.The multiple tubes 2704 a-c may provide a taut and substantially evensurface of the LAA wall for puncture, as represented in FIG. 27A. Anarrow puncture site is preferably provided. The tissue-penetrating tip2102 may be able to penetrate the surface of the LAA wall at asubstantially perpendicular angle. In one embodiment, a plurality ofregions may be coupled to the central tube 2706, each providing asuction force.

FIG. 27B illustrates the suction device 2702 without the LAA wall beingshown.

FIG. 27C illustrates a front view of the end of the suction device 2702,displaying the lumen 2708 for receiving the tissue-penetrating tip 2102and accompanying body of the penetrating device. The multiple tubes 2704a-c are displayed at spaced apart positions on the central tube 2706.The multiple tubes 2704 a-c may be positioned outside and adjacent tothe central tube 2706 where the tip 2102 will be inserted.

The embodiments shown in FIGS. 25-27 may provide for additional controlof the LAA during puncture of the LAA, and reduction of undesiredpuncturing and bleeding of the LAA.

A method corresponding to one or more of the embodiments of FIGS. 25-27and/or one or more embodiments disclosed herein or incorporated byreference herein may include applying a suction force to a surface of aLAA with a suction device, and puncturing the surface of the LAA using atissue-penetrating tip while the suction force is applied to thesurface. The suction device may comprise a plurality of tubes. Theplurality of tubes may be coupled to a central tube. Thetissue-penetrating tip may comprise a tip of a body extending within thecentral tube. The central tube may not apply a suction force to thesurface of the LAA while the surface of the LAA is punctured using thetissue-penetrating tip. The plurality of tubes may be spaced apart fromeach other on the central tube. The central tube may include a lumen forthe tissue-penetrating tip to extend through. The surface of the LAA maybe a wall of the LAA, and a step of puncturing may comprise puncturingthe wall of the LAA with the tissue-penetrating tip from exterior of theLAA to interior of the LAA. The method may incorporate other methodsteps or systems disclosed herein or incorporated by reference herein.

The systems and methods disclosed in regard to FIGS. 25-27 may beincorporated into any system or method disclosed in this application orin U.S. patent application Ser. No. 14/941,457.

FIG. 28 illustrates an embodiment of the present disclosure in which aninflatable balloon 2802 is inflated within a cavity of the LAA 2406. Theinflatable balloon 2802 may be coupled to a sheath 2804 that is passedthrough a wall of the LAA, in any manner disclosed in this applicationor in U.S. patent application Ser. No. 14/941,457. The LAA may beentered from the exterior/pericardial space that has been accessedsurgically.

The inflatable balloon 2802, upon inflation, may apply pressure againstan interior surface of the LAA. The pressure applied by the inflatableballoon 2802 may be applied in a direction towards the exterior of theLAA. The pressure applied by the inflatable balloon 2802 may be providedby the pressure of inflation, or may be provided by a force caused bythe sheath 2804 being drawn in a direction towards the exterior of theLAA. The inflatable balloon 2802 may be inflated and pulled back towardsthe entry site.

A pressure applicator device 2808 may be used to apply pressure to theLAA in a direction opposite to the pressure applied by the inflatableballoon 2802. The pressure applicator device 2808 may be pushed towardsthe LAA wall. The pressure applicator device 2808 may comprise a sleeveor other form of pressure applicator device that is configured to applypressure to the outer surface of the LAA. In the embodiment shown inFIG. 28, the pressure applicator device 2808 may have a funnel shapeconfigured to contour to the shape of the LAA. The funnel shape mayincrease the area over which pressure is applied. In one embodiment, thepressure applicator device 2808, and/or the inflatable balloon 2802 mayhave shapes that complement each other. For example, in one embodiment,the inflatable balloon 2802 may have a conical shape and the pressureapplicator device 2808 may have a funnel shape.

The pressure applicator device 2808 may be coupled to the sheath 2804. Alocking mechanism 2810, such as a spring locking mechanism disclosed inthis application may be used to maintain the forces provided by both theinflatable balloon 2802 and the pressure applicator device 2808. Thelocking mechanism 2810 may be used to hold and lock the inflatableballoon 2802 and the pressure applicator device 2808 in positionrelative to each other.

The pressures applied by the inflatable balloon 2802 and the pressureapplicator device 2808 may comprise counter-pressures. The pressures maybe applied in opposite directions. The counter-pressures maysubstantially counter balance each other. The counter-pressures mayserve to provide a compressive force against a wall of the LAA in bothan endocardial and an epicardial direction. The compressive force mayserve to seal the LAA ostium or the LAA puncture site, and/or preventbleeding from the wall of the LAA.

With epicardial surgical cannulation of the LAA and a subsequentinflation of a balloon within the LAA, it may not be necessary toprovide a system of multiple balloons or expanding elements adhering toeach other with a balloon inflated within the left atrial cavity toachieve a tight seal across the LAA ostium. The operator may have readyaccess to the pericardial cavity and epicardial surface of the LAA, and,after inflating a balloon in the LAA cavity, pressure can be appliedwith a constricting device or loop from the epicardial surface. Thepressure provided by the inflatable balloon 2802 and the pressureapplicator device 2808 may comprise counter-pressures, that serve tocounterbalance the pressure from the other device. The termcounter-pressure refers to a pressure applied in one direction tocounterbalance pressure from another. As such, as shown in FIG. 28, apressure may be applied to both sides of the LAA, in a circumferentialmanner, near the puncture site. The wall of the LAA is compressed fromboth the endocardial and epicardial directions. Hemostasis may bedesirably maintained within the LAA.

FIG. 29 illustrates an embodiment of a pressure being applied by aninflatable balloon 2902 in a similar manner as disclosed in regard tothe embodiment of FIG. 28. The LAA may be entered from theexterior/pericardial space that has been accessed surgically. Theinflatable balloon 2902, however, has a first portion 2904 and a secondportion 2906. The first portion 2904 may have a different degree ofcompliance than the second portion 2906. The first portion 2904, forexample, may be less compliant than the second portion 2906. The firstportion 2904, as shown in FIG. 29 may also have a wider diameter thanthe second portion 2906.

The pressure applicator device 2908 may have a funnel shape tocomplement the conical shape of the second portion 2906. The inflatableballoon 2902 and pressure applicator device 2908 may each provide acounter-pressure that counter balances each other in a similar manner asdisclosed in regard to the embodiment of FIG. 28. The pressureapplicator device 2908 may be pressed against the outer surface of theLAA wall, and the inflatable balloon may be inflated to provide apressure against the inner surface of the LAA wall, or may be drawntowards the inner surface of the LAA wall. An effective counter pressuremay be provided in the embodiment of FIG. 29 that is achieved over alarger area than shown in regard to the embodiment of FIG. 28.

FIG. 30 illustrates an embodiment of the present disclosure in which aninflatable balloon 3002 is inflated within a cavity of the LAA 2406. TheLAA may be entered from the exterior/pericardial space that has beenaccessed surgically. The inflatable balloon 3002 may be coupled to asheath 3004 that is inserted into the cavity of the LAA 2406. The sheath3004 may pass through a wall of the LAA 2406. The inflatable balloon3002 may include an indentation 3006. The indentation 3006 may have theform of a groove that extends circumferentially around the balloon 3002.The indentation 3006 may be pre-formed into the inflatable balloon 3002.

In the embodiment shown in FIG. 30, a constricting tie 3008 may beapplied around the exterior surface of the LAA 2406. The constrictingtie 3008 may take the form of a band or other device configured toconstrict the LAA 2406. The constricting tie 3008 may be positioned overthe exterior surface of the LAA 2406 and may engage the indentation 3006of the balloon 3002 through the wall of the LAA 2406. The indentation3006 of the balloon 3002 may serve to prevent the tie 3008 from slippingupon being placed on the LAA 2406. The tie 3008 may serve to maintainhemostasis for the LAA 2406. Although not shown in this Figure, anembodiment includes suction tubes attached to the surface of the balloon3002. Upon application of suction, the LAA wall will adhere effectivelyto the inflated balloon and thus prevent bleeding from the puncturesite.

The embodiments shown in FIGS. 28-30 may provide for hemostasis of theLAA 2406 after puncturing the structure. The embodiments shown in FIGS.28-30 may provide for a hemostasis of the LAA 2406 without use ofmultiple balloons within the LAA and/or within the left atrium.

A method corresponding to one or more of the embodiments of FIGS. 28-30and/or one or more embodiments disclosed herein or incorporated byreference herein may include inflating an inflatable balloon within thecavity of the left atrial appendage (LAA), and applying pressure to aninterior surface of the LAA, with the inflatable balloon, in a directiontowards exterior of the LAA. The method may include applying pressure toan exterior surface of the LAA, with a pressure applicator device, in adirection towards the cavity of the LAA while the pressure to theinterior surface of the LAA is being applied with the inflatable balloonto the interior surface in the direction towards exterior of the LAA.The pressure applicator device may be a sleeve extending over theexterior surface of the LAA. At least a portion of the pressureapplicator device may have a shape that complements a shape of at leasta portion of the inflatable balloon. The pressure that is applied to theinterior surface of the LAA and the pressure applied to the exteriorsurface of the LAA may compress a wall of the LAA in both theendocardial and the epicardial directions. The inflatable balloon mayhave a first portion that is more compliant than a second portion of theinflatable balloon. The pressure that is applied to the interior surfaceof the LAA may substantially counter balance the pressure applied to theexterior surface of the LAA. The inflatable balloon may have anindentation. The method may further comprise applying a constricting tieto an exterior surface of the LAA to engage the indentation of theinflatable balloon through a wall of the LAA. The method may alsoinclude application of suction from the surface of the inflatableelement that is deployed within the LAA. The method may incorporateother method steps or systems disclosed herein or incorporated byreference herein.

The systems and methods disclosed in regard to FIGS. 28-30 may beincorporated into any system or method disclosed in this application orin U.S. patent application Ser. No. 14/941,457.

FIG. 31 illustrates an embodiment of the present disclosure in whichsuction devices are utilized with one or more of the inflatable balloons102, 104, 115. The suction devices may take the form of tubes 3102 thatare coupled to one or more of the inflatable balloons 102, 104, 115. Thesuction devices may be configured to provide a suction force. Thesuction force may be used to attract any of the balloons 102, 104, 115to each other, or may be used to attract any of the balloons 102, 104,115 to an interior surface of the LAA. The suction force may be used toattract adjacent the balloons 102, 104, 115 to each other. In oneembodiment, the suction devices may be used to attract the balloons 102,104 to each other to seal the LAA ostium. In one embodiment, the suctiondevices may be used as a substitute for the electromagnetic coilsdisclosed in this application.

The suction devices may be coupled to any of the inflatable balloons102, 104, 115 as desired. In one embodiment, the suction devices may bepositioned on the outer surface of any of the inflatable balloons 102,104, 115. In one embodiment, the suction devices may be positioned onthe outer surface of inflatable balloons 102, 104, 115 proximate eachother, such that the suction devices are attracted to each other.

The suction devices disclosed in regard to FIG. 31 may be incorporatedinto any system or method disclosed in this application or in U.S.patent application Ser. No. 14/941,457. The suction devices may serve asa substitute for any means of attracting one feature of a system ormethod to another feature of the system or method, including the LAAitself.

FIGS. 32-35 illustrate a method and system for using at least onesuction device to maintain a hemostatic seal at the LAA ostium. In FIG.32, a plurality of inflatable balloons 102, 104, 115 are inflated withinthe cavity of the LAA. The balloon 102 may be coupled to an intermediatesheath 3202 which is positioned between the outer sheath 103 and innersheath 101. The inner catheter 117 extends exterior to the LAA to serveas a guide path for the closure device 1300, in a manner disclosed inthis application.

The suction device in the form of tubes 3102 may extend from one ormultiple of the inflatable balloons 102, 104, 115 to either createattachment between the respective balloon 102, 104, 115 and the interiorof the LAA, or between another balloon. Application of suction maycreate attachment of the balloon 104 with the wall of the LAA, close tothe ostium of the LAA. The suction device may be used to seal the ostiumof the LAA. In the embodiment shown in FIG. 32, tubes 3102 may be usedto attach the balloon 102 to the wall of the LAA. The balloon 102 may bea relatively non-compliant balloon and may alter and distend the shapeof the appendage.

The catheter 117 may perforate the LAA from within and enter thepericardial space while hemostasis is maintained. The exteriorizedcatheter 117 may be extended out to an exteriorized site.

In FIG. 33, the closure device 1300 is slid along the exteriorized innercatheter 117 and placed in position at the LAA ostium, as disclosed inthis application. The closure device 1300 may be advanced over theexteriorized catheter from outside and deployed at the ostium of theLAA. The balloon 115 may be deflated as shown in FIG. 33. The balloon102 may be deflated next in sequence. The balloon 104 may then bedeflated next in sequence.

In FIG. 34, the exteriorized catheter 117 may be gradually pulled outfrom the exteriorized site from where the closure device 1300 wasapplied. The balloon 119 at the end of the catheter 117 may be inflated.The inflated balloon 119 may prevent the catheter 117 from completelyexiting the LAA. The balloon 119 may include one or more suction devicesin the form of tubes 3102 to attract the balloon 119 to the innersurface of the LAA and secure the balloon 119 in position within the LAAcavity. The tubes 3102 may be positioned on an exterior surface of theballoon 119. A lumen of the catheter 117 may provide suction force inlieu of or in combination with the suction provided by the tubes 3102.

In FIG. 34, the balloon 115 has been deflated and the inner sheath 101has been retracted into the intermediate sheath 3202. The balloon 102has been deflated.

The intermediate sheath 3202 may be retracted into the outer sheath 103.The balloon 104 may be deflated. The sheaths 101, 3202, 103 may beretracted until fully withdrawn from the LAA in a direction towards theleft atrium cavity. FIG. 35 illustrates the sheaths 101, 3202, 103 fullyretracted. The balloon 119 remains in position as the walls of the LAAextend in a direction towards the interior of the LAA. The suctiondevice coupled to the balloon 119 continues to provide attachmentbetween the balloon 119 and the interior surface of the LAA. Theexteriorized catheter 117 will be removed from the LAA and drawn outthrough the exteriorized site.

A method corresponding to one or more of the embodiments of FIGS. 31-35and/or one or more embodiments disclosed herein or incorporated byreference herein may include inflating a first inflatable balloon withina cavity of a LAA, and applying a suction force with at least one tubecoupled to the first inflatable balloon to attract the first inflatableballoon to an interior surface of the LAA or to a second inflatableballoon. The second inflatable balloon may be positioned in a leftatrium cavity. At least one tube may be positioned on an exteriorsurface of the first inflatable balloon. The first inflatable balloonmay be coupled to a sheath positioned in the cavity of the LAA. Thefirst inflatable balloon may be coupled to a catheter extending througha wall of the LAA. The method may incorporate other method steps orsystems disclosed herein or incorporated by reference herein.

The method and system disclosed in regard to FIGS. 31-35 may beincorporated into any system or method disclosed in this application orin U.S. patent application Ser. No. 14/941,457.

FIG. 36 illustrates an embodiment of the present disclosureincorporating use of magnetic responsive materials 3601 with theinflatable balloons 102, 104, 115. In one embodiment, the magneticresponsive materials 3601 may take the form of a ferro fluid. Themagnetic responsive materials 3601 may be coupled to one or more of theballoons 102, 104, 115. In one embodiment, the magnetic responsivematerials 3601, such as a ferro fluid or magnetorheological fluid thatchanges viscosity in response to a magnetic field, may be positioned onan outer surface of one or more of the balloons 102, 104, 115, as shownin FIG. 36. The magnetic responsive materials 3601, such as a ferrofluid, may be inserted into a narrow tube stuck to the outer surface ofthe respective balloon. In one embodiment, the magnetic responsivematerials 3601, such as a ferro fluid, may be utilized to inflate one ormore of the balloons 102, 104, 115.

The magnetic responsive materials 3601 may be used to move any of theballoons 102, 104, 115, including attracting the balloons 102, 104, 115to each other, or to an interior surface of the LAA, upon exposure tomagnetic field. The balloons 102, 104, 115 may be caused to stick toeach other or to an interior surface of the LAA. The magnetic responsivematerials 3601 may be used to move one or more of the balloons 102, 104,115 by inflating the respective balloon. The movement of the one or moreballoons 102, 104, 115 may cause a seal of the LAA ostium. In oneembodiment, the magnetic responsive materials 3601, such as a ferrofluid, may be used as a substitute for the electromagnetic coilsdisclosed in this application.

The magnetic responsive materials may be controlled by an externalcontroller 3602. The external controller 3602 may produce a magneticfield 3604 that is used to move one or more of the balloons 102, 104,115 in a manner disclosed in this application or an applicationincorporated by reference herein. The external controller 3602 may bepositioned outside of the patient's body and the magnetic field may bepassed through the body. The external controller 3602 may be configuredto manipulate the magnetic field to control movement of the one or moreof the balloons 102, 104, 115. In one embodiment, an internal controllermay be utilized to move one or more of the balloons 102, 104, 115.

A method corresponding to one or more of the embodiments of FIG. 36and/or one or more embodiments disclosed herein or incorporated byreference herein may include inserting an inflatable balloon within acavity of a left atrial appendage (LAA) or a left atrium cavity, andapplying a magnetic field to a ferro fluid coupled to the inflatableballoon while the inflatable balloon is positioned within the cavity ofthe LAA or the left atrium cavity, to thereby move the inflatableballoon. The method may incorporate other method steps or systemsdisclosed herein or incorporated by reference herein.

The magnetic responsive materials disclosed in regard to FIG. 36 may beincorporated into any system or method disclosed in this application orin U.S. patent application Ser. No. 14/941,457. The magnetic responsivematerials may serve as a substitute for any means of attracting onefeature of a system or method to another feature of the system ormethod, including the LAA itself.

What is claimed:
 1. A method comprising: applying a suction force to asurface of a left atrial appendage (LAA) with a plurality of tubes; andpuncturing the surface of the LAA using a tissue-penetrating tip whilethe suction force is applied to the surface.
 2. The method of claim 1,wherein the plurality of tubes are coupled to a central tube.
 3. Themethod of claim 2, wherein the tissue-penetrating tip comprises a tip ofa body extending within the central tube.
 4. The method of claim 2,wherein the central tube does not apply a suction force to the surfaceof the LAA while the surface of the LAA is punctured using thetissue-penetrating tip.
 5. The method of claim 2, wherein the pluralityof tubes are spaced apart from each other on the central tube.
 6. Themethod of claim 2, wherein the central tube includes a lumen for thetissue-penetrating tip to extend through.
 7. The method of claim 1,wherein the surface of the LAA is a wall of the LAA, and the step ofpuncturing further comprises puncturing the wall of the LAA with thetissue-penetrating tip from exterior of the LAA to interior of the LAA.8. A method comprising: inflating an inflatable balloon within thecavity of the left atrial appendage (LAA); applying pressure to aninterior surface of the LAA, with the inflatable balloon, in a directiontowards exterior of the LAA; and applying pressure to an exteriorsurface of the LAA, with a pressure applicator device, in a directiontowards the cavity of the LAA while the pressure to the interior surfaceof the LAA is being applied with the inflatable balloon to the interiorsurface in the direction towards exterior of the LAA.
 9. The method ofclaim 8, wherein the pressure applicator device is a sleeve extendingover the exterior surface of the LAA.
 10. The method of claim 8, whereinat least a portion of the pressure applicator device has a shape thatcomplements a shape of at least a portion of the inflatable balloon. 11.The method of claim 8, wherein the pressure applied to the interiorsurface of the LAA and the pressure applied to the exterior surface ofthe LAA compresses a wall of the LAA in both the endocardial and theepicardial directions.
 12. The method of claim 8, wherein the inflatableballoon has a first portion that is more compliant than a second portionof the inflatable balloon.
 13. The method of claim 8, wherein thepressure applied to the interior surface of the LAA substantiallycounter balances the pressure applied to the exterior surface of theLAA.
 14. The method of claim 8, wherein the inflatable balloon has anindentation; and the method further comprises applying a constrictingtie to an exterior surface of the LAA to engage the indentation of theinflatable balloon through a wall of the LAA.
 15. A method comprising:inflating a first inflatable balloon within a cavity of a left atrialappendage (LAA); applying a suction force with at least one tube coupledto the first inflatable balloon to attract the first inflatable balloonto an interior surface of the LAA or to a second inflatable balloon. 16.The method of claim 15, wherein the second inflatable balloon ispositioned in a left atrium cavity.
 17. The method of claim 15, whereinthe at least one tube is positioned on an exterior surface of the firstinflatable balloon.
 18. The method of claim 15, wherein the firstinflatable balloon is coupled to a sheath positioned in the cavity ofthe LAA.
 19. The method of claim 15, wherein the first inflatableballoon is coupled to a catheter extending through a wall of the LAA.20. A method comprising: inserting an inflatable balloon within a cavityof a left atrial appendage (LAA) or a left atrium cavity; applying amagnetic field to a ferro fluid coupled to the inflatable balloon whilethe inflatable balloon is positioned within the cavity of the LAA or theleft atrium cavity, to thereby move the inflatable balloon.